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 .
Detailed Action
Summary
This is the Final Office action based on the 17/614140 RCE response filed 09/02/2025.
Claims 12-14, 16-23, & 25-29 are pending and have been fully examined.
Claims 1-11, 15, & 24 are cancelled.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title.
The claimed invention of Claims 12-14, 16-23, & 25-29 are directed to non-statutory subject matter.
The invention of instant claims 12-14, 16-23, & 25-29 are drawn towards a method of “monitoring,” a subject as having or at risk of having CDI (clostrioides difficile infection).
Through 101, inquiry analysis:
Are the claims directed to a statutory category of invention?
Yes, independent claim 12 & 21 are drawn towards a statutory category method.
Does the claim involve a Judicial Exception?
Yes. The claims involve the judicial exception which is an abstract idea. “Monitoring,” as the instant method for independent Claim 12 and it’s preamble is drawn towards is a mental process which is an abstract idea judicial exception. Step ii) of Claim 12 also requires “generating a ratio,” which is a mathematical concept, and “comparing,” which is a mental process, and both of these two things are abstract ideas as well.
Further, independent Claim 12 and those which depend therefrom include a law of nature/natural correlation judicial exception, which is the level of the claimed biomarkers (two or more analytes comprising 4-methylpentanoic acid (4-MPA)) in a biological subject with the presence of the CDI disease). Though the word diagnosis is not used, the diagnosis is implicitly there though not explicit.
These claims map most closely to USPTO Subject Matter Eligibility Example 29- drawn to the Julitis claims.
Analysis of other factors to determine if the claim qualifies as eligible and ismore than the natural correlation/abstract idea.
Step 2A/2-Do the claims practically apply the judicial exception?
There are no features instantly claimed which practically apply the judicial exception.
The claimed treatment step requires “administering to the subject having a ratio indicative of CDI an antibiotic selected from methicillin, glycopeptide, tetracycline, oxytetracycline, doxycycline, chlortetracycline, minocycline, glycocyclin, cephalosporin, ciprofloxacin, nitrofurantoin, trimethoprim-sulfa, piperacillin/tazobactam, moxifloxacin, vancomycin, teicoplanin, penicillin, and macrolide.”
This treatment does not read as particular or specific. First of all, the claim still reads as conditional in that a treatment is not always performed in the boundaries of the claim since the treatment is only based on the comparison. The “second antibiotic,” is only administered if certain conditions arise (ratio greater than or equal to threshold level which is indicative of active CDI). If a ratio below this level is found, no further treatment step occurs. Therefore- there is not always required to be a practical application.
Further—the claimed list of antibiotics which could be used as treatment is very generalized--- including---, “methicillin, glycopeptide, tetracycline, oxytetracycline, doxycycline, chlortetracycline, minocycline, glycocyclin, cephalosporin, ciprofloxacin, nitrofurantoin, trimethoprim-sulfa, piperacillin/tazobactam, moxifloxacin, vancomycin, teicoplanin, penicillin, and macrolide.” All of these treatments are used for many other infections, not only limited to CDI. Therefore--- what is claimed seems to be akin to “administering a suitable antibiotic.” Though this is slightly more specific--- the MPEP points out that “administering a suitable medication,” is not particular and specific treatment. See MPEP 2106.04 (d)(2):
“Consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This 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 mental analysis step into a practical application.”
Therefore- this treatment is not particular or specific as claimed. Also, see Vanda Memorandum.
Further Claim 12 also requires a general measurement step, step (i). However, this measurement is not done in a particular or specific way and as claimed is only used to gather data to perform the claimed judicial exceptions. See MPEP 2`05.95 (g). Therefore- this does not practically apply.
Claim 12 also requires that the subject has undergone or is undergoing treatment with a first antibiotic and is exhibiting one or more symptoms of CDI. This does nothing to change the analysis above. The, “first treatment,” as claimed is not performed within the boundaries of the claim, so not limiting in the claim language. The sample measured, is still a natural biological sample.
Step 2B-Do the claims result in significantly more than the judicial exception?
There are no features instantly claimed which result in significantly more than the judicial exception.
Instant independent Claim 12 requires “measuring the level of two or more analytes….,” which are 4-MPA and leucine “generating a ratio…,” and administering a treatment wherein the treatment is selected from a long list of possible antibiotics. As claimed there is no particular or specific measurement, analysis, or detection. The instant measurement is claimed at a level of generality that it is well understood routine and conventional (WURC) in the art. Things that are WURC do not make the claims significantly more. See MPEP 2106.05 (d).
With respect to the treatment step, due to the large variety of general antibiotics claimed, with no direction to as when one antibiotic is chosen over the other---the claimed list of antibiotics read as a general list of antibiotics that could work. All of the claimed antibiotics are routinely and conventionally used in the art and therefore WURC—and at the level of generality claimed do not read as being significantly more than the claimed judicial exceptions. Further- the claim still reads as conditional in that a treatment is not always performed in the boundaries of the claim since the treatment is only “based on” the comparison--- and in some instances the comparison could make the treatment, be no treatment at all.
The other & dependent claims undergo a similar analysis
Claims 13 & 22 do not change the matters above as they merely specify where the natural sample is taken from, and therefore it is still a natural sample and does not apply the judicial exception.
Claims 14, 17-19, 23 & 26-28 do not change the matters above as they merely specify what further biomarkers are and what levels they are measured at. This is part of the judicial exception claimed above and is not application of it.
Claims 16 & 25 specify that mass spectrometry is used to measure the biomarkers. Mass spectrometry however is a routine and conventional and well understood method used to identify biomarkers in the art. Therefore- at the level of generality claimed- this does not provide practical application to the judicial exception and does not change the matters above.
Claims 20 & 29 specify that the treatment can further be antimicrobial, antiviral, or anti-inflammatory.” All of these treatments are not particular or specific. All of these treatments are used for almost every disease/condition on the planet. Therefore, at the level of generality claimed—they are not particular or specific as they are routinely and conventionally used in the art, and also are akin to administering a “suitable,” treatment.
Claim 21 is drawn towards a method of treating, though it carries many similarities to Claim 12, claimed in a different way. Applicant seems to be trying to claim the instant subject matter in multiple different ways. It is noted for Claim 21 however that the only required step in Claim 21 is the administration of one of the many claimed possible antibiotics. That the subject, “has been determined to have an active CDI,” by having a threshold level of 0.00132, is not limiting in the claims as no measurement is done within the boundaries of the claims. That the subject is undergoing or “has undergone,” other treatment priorly is also not limiting in the claims, again, since this treatment is not occurring within the boundaries of the claim. Therefore- though Claim 21 is currently drawn towards “treating,” and the only real concrete step in claim 21 is a non-specific antibiotic treatment step, the claim is still rejected under 101. Claim 21 does not practically apply at step 2A/2 nor add significantly more at step 2B.
It is noted that once the dependent claims are added to Claim 21 (Claims 22-23 & 25-29), they make it read more similarly to claim 12 in that measurements of biological samples are required, a natural correlation is determined in relation to biomarkers, and basic measurement method of mass spectrometry. Therefore—the claims are still rejected under 101, even though Claim 21 as a whole reads as just non specific treatment/administration--- when taken as a whole with dependent claims coming into play the claim encompass the same judicial exceptions as in Claim 12.
Further, as the dependent claims require all limitations of the independent Claims, and Claims 26-28 point out that a treatment with the antibiotics in Claim 21 is only performed “when,” certain conditions apply and not all the time, Claim 21 and those dependent therefrom are not considered a particular practical application nor are they considered significantly more, for the same reasons as in Claim 12.
For more information see:
USPTO subject matter eligibility example 29
MPEP 2106.04 (b) & (d) which deals with Laws of Nature, Natural Phenomena & Products of Nature
MPEP 2106.05(d) which deals with what is considered “Well-Understood, Routine and Conventional & MPEP 2106.05 (g).
Vanda memorandum.
Claim Rejections - 35 USC § 112
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 26-28 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.
With respect to Claims 26-28, they claim that the antibiotic treatment in Claim 21 is only administered “when,” specific biomarkers are found in relation to threshold levels. This is unclear/confusing since Claim 21 which they depend from read that an antibiotic is always administered when the claimed biomarkers in Claim 21 are found above a certain threshold. Therefore, it is not clear is Claims 26-28 is attempting to broaden the claim, in saying that the second antibiotic, which is already required to be administered in some instances in Claim 21, is required in other instances which weren’t present or monitored in Claim 21. Therefore—Claims 26-28 are broadening on the base claim 21, and are unclear for this reason. Further—Claims 26-28, like Claim 21, still do not require any measurement or detection in the claim only the “when,” result, which also makes the claims unclear. This requires correction. It is noted that this clarity problem also plays into why Claim 21 and those dependent therefrom are interpreted as ineligible under 101.
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.
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 non-obviousness.
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.
Claims 12-14, 16-23, & 25-29 are rejected under U.S.C. 103 as being obvious by SAVIDGE in US 20140296134 in view of GARNER in Volatile organic compounds from feces and their potential for diagnosis of gastrointestinal disease and further view of MILBURN in US 20170089872.
Regarding claim 12, & 21, SAVIDGE teaches a method of treating a subject having a Clostridioides difficile infection (CDI) (para [0053, 0006], in certain aspects methods of treating C. difficile infection comprises providing phytic acid supplements or stable phytic-acid derivatives"; para [0054], "Certain embodiments include the identification and/or categorization of metabolite profiles in stool samples (the stool metabolome) and identification of certain aspects of the metabolite profile as biomarkers of pathology, clinical phenotype, activity, and/or treatment"). SAVIDGE further teaches of monitoring and predicting progression of the disease (paragraphs 0033 & 0035, 0055, 0099). SAVIDGE further teaches of monitoring if the treatment is effective or not (paragraph 0115), and of treating and then supplementing treatment if need be (paragraphs 0128-0131), which can sometimes include a second or combinations of antibiotics (Claim 9).
The method comprising:
(i) measuring levels of one or more analytes selected from the group consisting of a short chain fatty acid, an amino ‘acid, a bile acid, a carbohydrates, an aromatic alcohol and a lipid in a biological sample obtained from the subject (abstract; para [0006], "In certain embodiments a metabolic profile can identify a subject with CDI or who has or is at risk for recurrent CDI"; para [0007].
SAVIDGE further teaches of detecting and of measuring a p value less than (meaning statistically significant) .05, .1, and .5 for isoleucine and leucine compounds (paragraphs 0086- 0089).
SAVIDGE further teaches, “In a further aspect analysis of the stool metabolome is used to identify subjects having an increased risk of disease relapse or recurrence of CDI... Increases or decreases in metabolites related to bacterial activity and inflammation are evident in CDI patients, e.g.,... bile acid conjugation”; para [0058], "Metabolites identified in the metabolome are used as biomarkers... Detection and analysis of a biomarker specific to a disease can aid in the identification, diagnosis, and treatment of the disease... biomarkers related to CDI include, but are not limited, to metabolites associated with... bile acid metabolites"; para [0097], "Data is collected during analysis and quantifying data for one or more than one metabolite is obtained");
(ii) determining an analyte signature based on the expression levels of the analytes in step (|) (para [0006], “Metabolomics refers to the study of the complete set of metabolites (the metabolome) in a biological sample under a given set of conditions... the metabolome is highly responsive to pathophysiological conditions, thus making it ideally suited to distinguish subtle disease phenotypes. The inventors have been able to successfully identify biochemical profiles in clinical specimens that classify CDI with a high degree of confidence... This unique technique uses visual analytical approaches to discover and validate patterns in biomedical data, and translate those discoveries into clinical practice"; para [0085) - (0086), "Certain embodiments used a metabolome defined by compounds including metabolites having: (i) p-value of less than 0.005... serine"; para [0097], "Data is collected during analysis and quantifying data for one or more than one metabolite is obtained. “Quantifying data” is obtained by measuring the levels or intensities of specific metabolites present in a sample. The quantifying data is compared to corresponding data from one or more than one reference sample..."; para [0112], "the inventors select the most significant variables from the quantitative analysis to build a classifier... Two approaches can be used for developing a panel! of biomarkers that indicate a condition, e.g., CDI.... In certain aspects, the probability of the binary outcome is modeled against a set of predictor variables and after adjustment for individual characteristics");
(iii) assessing CDI occurrence or severity of the subject based on the analyte signature determined in step (ii) (para [0055], "Based on recent findings, the concept is that the stool metabolome can be used to predict disease type and progression in subjects, such as CDI patients”; para [0057], “Certain aspects include methods comprising one or more of (a) identifying patterns in the stool metabolome across subjects having a condition and controls-in certain aspect the patterns can be identified using network visualization and analysis; (b) verifying the patterns through graph-based and biostatistical methods; and (c) translating the patterns into new approaches for classifying subjects based on predictive models "; para [0097], "The quantifying data is compared to corresponding data from one or more than one reference sample. The "reference sample” is any suitable reference sample for the particular disease state..."; para [0112}); and
SAVIDGE further teaches of treating the subject with an anti-CDI therapeutic when the analyte signature in step (i) relative to a reference value indicates the subject has CDI (para [0097], which includes antibiotics such as vancomycin (a claimed option for the antibiotic) (paragraph 0004, 0053, 0128). "The quantifying data is compared to corresponding data from one or more than one reference sample. The "reference sample" is any suitable reference sample for the particular disease state..."; para [0034), and it is further taught of comparison to a control population (paragraph 0030, 0100).” In certain aspects methods of treating C. difficile infection comprises providing phytic acid supplements or stable phytic-acid derivatives"; para [0131], "The inventors identified phytic acid supplementation as a treatment for C. difficile infection"; para [0130], "Other therapies include administering therapeutic antibodies. Therapeutic antibodies include those antibodies that bind and inhibit C. difficile or C. difficile toxins, the inhibition of which provides a therapeutic benefit’).
SAVIDGE teaches of detection of leucine as shown above, but does not teach of the detection of 4-MPA specifically, nor do they teach of detection of ratios of biomarkers.
GARNER is used to remedy this and more specifically teaches of a method for detection of volatile organic compounds from feces of those with clostridium dificile infections (abstract), and specifically of detection 4-methyl pentanoic acid (Page 1678, Table II, line 18). GARNER teaches of the level of 4- methyl pentanoic acid in those with clostridium dificile infection being lower than in asymptomatic patients (Page 1678, Table II).
It would have been obvious to one of ordinary skill in the art to detect 4- methyl pentanoic acid as is done in GARNER in the method of SAVIDGE due to the advantage it shows for being diagnostic by measuring at levels which are different for patients who are asymptomtic, have ulcerative colitis, clostridium dificile infection and campylobacter jejuni infections (Table 2) and due to the potential VOCs such as 4 methylpentanoic acid offer for developing methods of developing rapid diagnosis of gastrointestinal diseases(Page 1675, first column, last paragraph and second column, first paragraph).
SAVIDGE and GARNER do not teach of detecting the ratios of the compounds (4-MPA and leucine) to one another.
MILBURN is used to remedy this. MILBURN teaches of a method for profiling individuals for disease (abstract), and the diseases can be from things like bacterias (paragraph 0074) (which clostridium dificile which is instantly claimed is one of).
MILBURN further teaches of detecting the biomarkers 4-methyl-2-oxopentanoate (a slight derivative of 4-methyl pentanoic acid (MPA)) and leucine together as biomarkers (paragraph 0235). MILBURN further teaches of detecting the ratios of biomarkers to one another (paragraph 0149).
MILBURN even further teaches of monitoring the disease severity (paragraph 0494), and of monitoring the effect of the treatment (Example 4, paragraph 0493) and ensuring/changing treatment so that the treatment is effective (paragraph 0151).
It would have been obvious to one of ordinary skill in the art to detect the levels/ratios of biomarkers to one another as is done in MILBURN in the methods of SAVIDGE and GARNER due to the advantage this offers for determining disease state in a subject (MILBURN, paragraph 0149).
SAVIDGE, GARNER, and MILBURN do not call out that the threshold level/ratio of 4-MPA over leucine is 0.00132 and that a ratio over this indicates CDI. As the claimed ratio/level is diagnostic though--- this level would be necessarily present in any patient found to have a clostridium dificile infection (patients with this infection are shown in both SAVIDGE and GARNER), as this is how diagnostics work.
Further since SAVIDGE and GARNER teach of detection of 4-MPA and leucine and their separate association with clostridium dificile infection, it would have been obvious to one of ordinary skill in the art to discover the optimum or workable range of a detection ratio utilizing the two through routine experimentation/optimization. See MPEP, 2144.05.
The examiner further notes that as claimed it seems that this ratio is magically generated as no detection method, or detection units are claimed, nor is any kind of equation for how the ratio is generated/calculated.
It is further noted that for Claim 21--- the only real positively claimed step is the administration of one of the claimed antibiotics which SAVDIGE teaches by itself as shown in the above rejection. The claimed limitation of “wherein the subject has been determined to have an active CDI,” is not read as occurring within the boundaries of the claim. However- in case this is unclear to one of ordinary skill in the art—GARNER and MILBURN solve any deficiencies as shown above.
With respect to Claims 13 & 22, SAVIDGE teaches the method of claim 12, wherein the biological sample is a fecal sample (abstract, "Embodiments | include methods for generating a metabolite profile of a stool sample and methods of assessing the status of a subject using the metabolic profile derived from a stool sample").
With respect to Claims 14, 18, 23, 27, 28 SAVIDGE teaches of the analyte being isoleucine (paragraph 0087-0090). See Claim 12 rejection for comparison to reference. Also see rejection for Claims 15 & 24 below.
With respect to Claims 16 & 25, SAVIDGE teaches the method of the claims above, wherein the wherein the analyte levels are measured by mass spectrometry (para [0096], "The metabolites are generally characterized by their accurate mass, as measured by mass spectrometry technique used in the above method").
With respect to Claims 17, 18, & 26, SAVIDGE teaches of measuring and elevated/increased or decreased level relative to a control/reference level (paragraph 0030, 0127). SAVIDGE also teaches of measuring a p value less than (meaning statistically significant) .05, .1, and .5 for isoleucine and leucine compounds (paragraphs 0086- 0089). This makes it obvious to one of ordinary skill in the art to look for any levels (increased or decreased) that are statistically significant in comparison to a normal level of isoleucine compounds.
SAVIDGE and GARNER do not call out the detection of allo-isoleucine.
MILBURN is used to remedy this. MILBURN teaches of a method for profiling individuals for disease (abstract), and the diseases can be from things like bacterias (paragraph 0074), and further of detection of allo-isoleucine (paragraph 0326). It would have been obvious to one of ordinary skill in the art to measure allo-leucine variant as is done in MILBURN in the method of SAVIDGE and GARNER, and one would expect success due to the advantage assaying for the combination of leucine and isoleucine and allo isoleucine in addition to the 700 other metabolites, offers in surveying metabolites across eight biochemical pathways (MILBURN, paragraph 0063).
With respect to Claims 20 & 29, SAVDIGE teaches of administering an anti-inflammatory agent (paragraph 0139).
Response to Arguments
Applicant's arguments filed 09/02/2025 have been fully considered but they are not persuasive.
Some of the prior 112 rejections are overcome due to the instantly made amendments, however others remain and the reasons are shown for this in the rejections above.
The 101 rejection is maintained for the reasons shown above for the claims which were amended significantly 09/02/2025. These amendments are addressed in the rejection above.
Applicant argues that the instant claims are like those in the Vanda application, but the examiner disagrees. As claimed, the claimed treatment is not always required (specific) and is not particular to CDI, as the claimed antibiotics are used routinely for a large variety of conditions. Also, the claims are left open to occurrences where no treatment happens. In the Vanda claims--- there was in fact particular and specific treatment in every instance in the claim, and this is not the case instantly. This even holds true for Claim 21, which is drawn towards treating, however the dependent claims making what is actually required for Claim 21 (is there actual measurement or not? Is there are determination of a natural correlation or disease) somewhat unclear.
The examiner also maintains that the instant claims differ from USPTO subject matter eligibility example 43 for the same reasons. In Claim 12, unlike Claim 43--- again the claim is left open to occurrences where no treatment occurs.
For Claim 21, as no ratio or measurement or calculation of a ratio is required in the positive claims steps, all that is claimed is very general administration of one of the claimed general antibiotics. This is unlike Claim 43 of the USPTO eligibility examples. Claim 21 (especially when including the dependent claims) is somewhat unclear as to what is required in the claims and what is not. Applicant seems to want the judicial exception to be required for the claims (but only in the pre-processing) before the claims occur. The treatment claimed seems to be akin to instructing a person following the method to choose a suitable antibiotic or medication (since there is a very large list of commonly used antibiotics listed). As shown above, these kinds of things are not considered to practically apply nor add significantly more to the judicial exceptions.
Therefore, all claims remain rejected under 101.
With respect to the prior art, applicant has submitted a Declaration/Affidavit by Dr. Henderson, dated 09/02/2025. The Declaration was very informative and helpful, however it does not change matters with respect to what is currently claimed. In the fashion the instant invention or discovery is claimed, it is not patent eligible and therefore rejected under 101.
Applicant’s arguments with respect to the prior art, also focus on the Henderson Declaration. With respect to this, the examiner understands that they had to use multiple references, and that these references do not recognize the claimed numerical threshold ratio of 4-MPA /leucine applicant has found to be indicative of whether a patient has CDI. Unfortunately, recognition/discovery of a natural correlation is not patent eligible, even if applicant thinks it is unexpected or surprising, unless applicant can claim it in a way which practically applies or adds significantly more to the natural correlation or abstract idea judicial exception. As currently claimed, this is not the case.
Applicant further argues that a person of ordinary skill would not have been above to predict this instantly claimed method based on the combination of references used by the examiner. Though the examiner sees why applicant argues this, the examiner notes, though not teaching of some of the claimed judicial exceptions (the specific claimed ratio number claimed, only in Claim 12) the prior art does still make these judicial exceptions obvious for the time being as the prior art teaches of the claimed concrete, non-abstract, and non-natural correlation steps. This is in addition to teaching of the claimed association of leucine and 4-MPA to diseases.
If applicant is able to overcome the 101 issues with amendments, then the prior art will be further reviewed at that time as well.
All claims remain rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758