DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/4/2025 has been entered.
Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 16, 19-22, 26, 29-30, 33, 35, and 38 remain withdrawn. Claims 1, 4-14, and 40 are pending and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/4/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant’s Arguments and Amendments
Applicant has provided arguments related to the 35 USC 103 Rejections presented in the Final Rejection mailed 3/4/2025. Specifically, Applicant states that the combination of references provided do not teach amplifying an HCV core nucleic acid sequence with primers of SEQ ID NOs: 1 and 2, as required by claim 1 (Remarks, page 10, para. 2). Tanabe, used to teach SEQ ID NO: 2, allegedly only teaches that the sequence comprising SEQ ID NO: 2 (SEQ ID NO: 43 of Tanabe) is found in the core region of HCV subtype 2b, and not any other subtype, and so does not teach detecting all of HCV subtypes 1-6 (Remarks, page 11, para. 1). Regarding Zhou, as the reference teaches three probes in combination, where one probe contains the sequence of instant SEQ ID NO: 1, Zhou allegedly does not teach that these probes can be used individually, and also does not show that these probes or a primer pair can amplifying all of HCV genotypes 1-6. Zhou allegedly teaches away from the instant invention as it does not teach a primer sequence that overlaps with the core sequence as found within the present invention (Remarks, page 12, para. 1). Moghaddam fails to overcome this alleged deficiency.
Applicant also argues that that their invention is non-routine and produces non-predictable results. Applicant states that their invention has several properties not present in the prior art, as the combination of references presented allegedly does not teach each aspect of the instant invention, either alone or in combination (Remarks, pages 14-15). Applicant also provides evidence of allegedly unexpected results related to the use of their primers (Remarks, pages 15-18).
In response to Applicant’s arguments regarding the cited references, Applicant argues the teachings of both the references and the instant claims too narrowly. In the instant claims, the method requires detecting HCV nucleic acids where the primer pair must hybridize to an HCV core nucleic acid sequence conserved across HCV genotypes 1-6, but the actual detection of all of HCV genotypes 1-6 in the sample is not required. Furthermore, as the primer pair of SEQ ID NOs: 1 and 2 (or sequences at least 95% similar to them) is recited as the claimed primer pair, the claim attempts to establish that these sequences inherently hybridize to such a conserved region. This is further evidenced by Figure 2 and page 21, para. 7 of the instant specification, which show where SEQ ID NOs: 1 and 2 hybridize to the HCV core region, and Figure 3, page 6, para. 4, and page 21, para. 8 of the instant specification, which show where SEQ ID NOs: 1 and 2 align with HCV genotypes 1-6. Thus, if the prior art teaches or suggests the use of SEQ ID NOs: 1 and 2 as primers, this would inherently meet the limitation of teaching a primer pair that hybridizes to a HCV core nucleic acid that is conserved between HCV genotypes 1-6.
As to the teachings of the references, firstly, it is noted that MPEP 2141.03 I states that, “‘"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.’ KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). ‘[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.’ Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ.’ Id. at 418, 82 USPQ2d at 1396.” In the Final Rejection, Miick was used to teach use of isothermal amplification of HCV nucleic acids with primer pairs, as well as quantifying multiple HCV genotypes simultaneously, and methods of primer design. Tanabe teaches a sequence comprising SEQ ID NO: 2, along with methods of primer design, particularly based upon core conserved regions across HCV genotypes. Zhou teaches a sequence comprising SEQ ID NO: 1, as well as primer/probe design based on regions conserved among HCV genotypes. Moghaddam teaches more specific commercially available materials and software for primer design based on conserved HCV regions (see the Final Rejection, paras. 22-25). The Examiner asserts that the ordinary artisan could combine these teachings, knowledge known to the ordinary artisan, and ordinary creativity, to arrive at the claimed invention. SEQ ID NOs: 1-2 were generally already known in the prior art, as evidenced by Tanabe and Zhou. Limiting the sequences described by these references to only the uses described by the references would be improperly limiting the ability of the ordinary artisan. The inclusion of the teachings of Miick, Tanabe, Zhou, and Moghaddam regarding designing primers, genotyping, and targeting conserved HCV regions across multiple genotypes are evidence of additional uses for HCV sequences that would be possible for the ordinary artisan. Though the references do not specifically teach the use of instant SEQ ID NOs: 1-2 as primer sequences, utilizing HCV sequences as primers to detect HCV would be possible for the ordinary artisan, and so, in the absence of specific unexpected results associated with the claimed sequences, the generation of primers comprising SEQ ID NOs: 1-2 for use in a method as taught by Miick would be possible for the ordinary artisan, rendering the claimed invention non-obvious.
To Applicant’s point that the prior art does not demonstrate all the properties of the claimed invention, Applicant specifically points out the Examiner’s findings that Miick does not contemplate using primers that hybridize to regions outside of the 5’ UTR, Tanabe does not note Applicant’s results or advantages, and that no art could be found that teaches sequences consisting of SEQ ID NOs: 1-2 together. These findings by the Examiner were used when discussing Applicant’s allegations of unexpected results, and do not necessarily coincide with the limitations of the instant claims. This list also points out differences between the individual references and the claimed invention, but the obviousness rejection relies on the combination of the references and their teachings. As noted above, taken together, these references teach the method of claim 1. As the references teach the use of SEQ ID NOs: 1-2, they inherently teach a primer pair that hybridizes specifically to an HCV core nucleic acid that is conserved between HCV genotypes 1-6. This primer pair also inherently targets a portion outside the 5’ UTR in the case of SEQ ID NO: 2 (see para. 10 of the Final Rejection). Thus, when considering the actual claim limitations and the combination of Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam, this list alone is not sufficient to be considered evidence that the claimed invention contains properties not present in the prior art.
Furthermore, as to Applicant’s provided evidence showing allegedly unexpected results, Applicant compares HCV detection from different primer pairs than those claimed. This appears to be from data generated by Applicant, where the non-claimed primers could detect HCV at 5,000 IU/mL. The claimed primer pair could detect HCV at much lower concentrations. It is not specifically stated that the non-claimed primer pairs could not detect HCV at lower concentrations, and so the comparison of performance between the groups of primer pairs is not entirely clear for all concentrations. Applicant also points to Figure 5 to show the detection of HCV genotypes 1-6 “using a method according to an embodiment of the invention,” where plasma samples diluted in whole blood were used and subtypes were detected at 3,000 IU/mL (page 23, para. 2 of the instant specification). Page 24 of the instant specification notes that SEQ ID NOs: 1-4 were used in generating the data for Figure 5 (see Remarks, pages 16-18).
While these results may generally show that SEQ ID NOs: 1 and 2 can detect HCV sequences at low concentrations, and can detect HCV genotypes 1-6 when used with probes, these results do not necessarily show unexpected results when compared to other primers in the context of the claimed invention. The claimed sequences include SEQ ID NOs: 1-2, but also sequences that are at least 95% similar to SEQ ID NOs: 1-2. The claimed sequences also comprise SEQ ID NOs: 1-2 or sequences with at least 95% similarity to these sequences, and so can include additional nucleotides. Thus, the results shown for SEQ ID NOs: 1-2 alone are not commensurate in scope with the claimed invention. Additionally, it is not clear that the primers used for comparison with SEQ ID NOs: 1-2 were tested at concentrations lower than 5,000 IU/mL.
Overall, Applicant has not yet met the burden for demonstrating unexpected results. The 35 USC 103 Rejections presented in the Final Rejection mailed 3/4/2025 are therefore maintained and are reiterated below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-8, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Miick et al. (US 2018/0291474 A1), in view of Tanabe et al. (US 8,008,045 B2), in view of Zhou et al. (CN 106282404 A) and in view of Moghaddam et al. (Journal of Viral Hepatitis, 2006).
Miick teaches oligomers, compositions, and kits for detecting and quantifying Hepatitis C virus (HCV; Abstract). Methods of the invention involve using amplification oligomers that hybridize to HCV, performing an amplification reaction, and detecting the amplicons (para. 7). The amplification oligomers can be promoter primers (para. 101). Miick also teaches that an amplification reaction can involve at least one amplification oligomer oriented in both the forward and reverse directions, and that an in vitro amplification reaction may be used (para. 177). Miick notes that exponential amplification can occur in vitro and that isothermal amplification is an exponential amplification (paras. 186 and 46; instant claim 15). Miick also teaches that the methods of the invention can quantify multiple HCV genotypes simultaneously (para. 195). This reference also recites SEQ ID NO: 64, which comprises the RNA equivalent of instant SEQ ID NO: 2, and discusses methods of primer design using known sequences and alignments (paras. 214-217). Miick also discusses choosing assay targets for detecting multiple HCV genotypes using conserved regions, such as the 5’ untranslated region (Example 1, paras. 202-213).
However, Miick does not teach the DNA sequences of SEQ ID NOs: 1 or 2.
Tanabe teaches primers for isothermal amplification of HCV (Abstract). This reference also teaches SEQ ID NO: 43, which comprises the sequence of SEQ ID NO: 2. Tanabe also discusses methods of primer design (e.g. column 6, para. 7 and column 14, para. 2) and discusses designing primers based on core conserved regions across HCV genotypes (column 2, para. 4). Zhou teaches methods for detecting hepatitis in a sample (Abstract). This reference also discloses SEQ ID NO: 41, which is an exact match for SEQ ID NO: 1. This reference also discusses designing primers and probes based on regions common to all HCV genotypes using the same region discussed in Miick (the 5’ untranslated region, Zhou English translation, para. 50 and Miick para. 202).
Additionally, Moghaddam teaches methods of performing PCR on HCV strains (Abstract), and teaches developing primers and probes using commercially available materials and software (page 223, “Materials and Methods,” para. 1). This reference also teaches designing primers and probes based on the 5’ untranslated region of HCV, where portions of said primers and probes are conserved across genotypes (Figure 1 and pages 223-224, “Genotype specific amplification and detection”).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Miick, Tanabe, Zhou, and Moghaddam to arrive at the invention of claim 1. Miick teaches the general method of claim 1, and the teachings of Tanabe and Zhou would motivate one of ordinary skill in the art to include the instant HCV sequences not explicitly recited in Miick. In addition, the teachings of Moghaddam indicate that software for amplification primer and probe design is available and can be used by the ordinary artisan to obtain primers suitable for amplifying a known sequence (page 223, “Materials and Methods,” para. 1). In view of the above, the ordinary artisan would have been motivated to use the techniques and commercially available software disclosed in Moghaddam and the known HCV sequences disclosed by Tanabe and Zhou to design primers for use in the method of Miick, and in the absence of unexpected results, the claimed primers (instant SEQ ID NOs: 1-2) simply represent the result of an obvious series of steps. Tanabe provides additional motivation for the ordinary artisan, noting that “[HCV] genotyping enables determination of the incidence rate of acute hepatitis, the rate of becoming chronic and the possibility of shifting from hepatitis via liver cirrhosis to liver cancer, enables the prediction of efficacies of administration of an interferon selected depending on the subtype and enables the identification of contagion sources and infection route. Thus, the detection or determination of HCV by such a genetic test becomes superior to immunoassay,” (column 1, para. 5). Therefore, by developing additional primers and detection methods, patients outcomes may be improved and infectious events may be mitigated.
Therefore, claim 1 is prima facie obvious over Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam.
Regarding claim 4, Miick teaches compositions and methods involving reverse transcriptase (paras. 173-174). It would be obvious to include a reverse transcription step in the method of Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam before the amplification step, so that both RNA and DNA nucleic acids can be analyzed, thus expanding the pool of target nucleic acids that can be used and increasing the likelihood of HCV detection.
Regarding claim 5, Miick teaches DNA-dependent RNA polymerases, and teaches that promoters are specifically recognized by these polymerases (paras. 124 and 102). As noted above, the amplification oligomers of Miick can be promoter primers (para. 101), and therefore can bind to DNA-dependent RNA polymerases. These promoters can be at the 5’ end of a sequence (para. 111). Miick also teaches a method in which a third amplification oligomer binds to the target nucleic acid and reverse transcription occurs (para. 187). Miick also teaches a method in which isothermal amplification may be used after a linear amplification reaction, and that this amplification may involve a third amplification oligomer that is designed to hybridize to HCV sequences (paras. 46, and paras. 6-7 show examples of how a third amplification oligomer may be used). Multiple amplification oligomers can be used in these embodiments, where the first and second amplification oligomers can act as forward amplification oligomers, while the third can act as a reverse amplification oligomer (paras. 139, 141, and 143-144). Therefore, the ordinary artisan would be able to combine the teachings of Miick to arrive at the instant invention of claim 5. This can be done specifically using the existing structure of the “third amplification oligomer” with its promoter and sequence for hybridizing to a reverse transcriptase, and using it as the reverse primer in the method of Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam recited above in relation to claim 4. The results of this combination would be predictable, as it would still result in the detection of HCV in a sample.
Regarding claim 6, Miick teaches that the methods of the invention can involve capturing and isolating the target nucleic acids before performing subsequent steps (para. 176). It would therefore be prima facie obvious to also perform these steps before the reverse transcription and amplification steps in the method of Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam recited above in relation to claim 4.
Regarding claims 7-8, Miick teaches capture probes that can be provided along with amplification oligomers (paras. 16 and 115). Miick also teaches SEQ ID NO: 83, which comprises instant SEQ ID NO: 3. While SEQ ID NO: 83 is taught as a primer, it would be prima facie obvious to the ordinary artisan that it could also be used as a probe, as by design it can also hybridize to target HCV sequences.
Regarding claims 13-51, Miick teaches that the sample used can be a biological sample that may be from a living human that may have HCV, and may specifically be from blood or plasma (para. 81).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Miick et al. (US 2018/0291474 A1), in view of Tanabe et al. (US 8,008,045 B2), in view of Zhou et al. (CN 106282404 A) and in view of Moghaddam et al. (Journal of Viral Hepatitis, 2006), and further in view of Kohara et al. et al. (US 6,201,166 B1).
Regarding claims 9-11, Miick teaches detection probes that may hybridize to amplified nucleic acids (para. 112), and that the detection step of the method may involve use of these detection probes (para. 189). Miick also teaches that these probes may comprise detectable labels that incorporate dyes, thus making them visually detectable (para. 114).
However, Miick does not specifically teach SEQ ID NO: 4.
Kohara teaches mouse models for HCV (Abstract). This reference specifically teaches SEQ ID NO: 2, which consists of instant SEQ ID NO: 4, as a primer for amplifying HCV (column 4, Example 3, paras. 1-2). Using this primer resulted in successful amplification (see Figure 4).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the sequence taught by Kohara as a probe in the method of Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam. This would be a substitution of the detection probe sequences of Miick for SEQ ID NO: 2 of Kohara. MPEP 2143 I (B) states, “The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.” Kohara teaches that SEQ ID NO: 2 can hybridize to HCV genes, and though the sequence of Kohara is a primer, the basic function of a primer or probe in the absence of amplification conditions is the same – i.e. hybridizing to a target sequence. Miick also teaches that primers or probes may have detectable labels, giving the ordinary artisan a reasonable expectation of success in using the primer described by Kohara as a detectably labelled probe (paras. 35 and 112). Therefore, the results of this substitution would be predictable. Additionally, because the sequence recited in Kohara is the same as instant SEQ ID NO: 4, it is capable of hybridizing to a sequence that is conserved between HCV genotypes 1-6, as instant SEQ ID NO: 4 can be found in the HCV core sequence (instant SEQ ID NO: 5). The ordinary artisan would be motivated to use the sequence described by Kohara as a common detection probe in order to detect the general presence of HCV, regardless of the specific genotype(s) that may be in a sample.
Therefore, claims 9-11 are prima facie obvious over Miick, in view of Tanabe, in view of Zhou, in view of Moghaddam, and further in view of Kohara.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Miick et al. (US 2018/0291474 A1), in view of Tanabe et al. (US 8,008,045 B2), in view of Zhou et al. (CN 106282404 A) and in view of Moghaddam et al. (Journal of Viral Hepatitis, 2006), and further in view of Lee et al. (The Journal of Infectious Diseases, 2010).
Regarding claim 12, Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam teaches the method of claim 7, as described above. However, none of these references teach that capture and/or detection can occur via a chromatographic dipstick assay.
Lee teaches an amplification-based assay for visually detecting HIV using a dipstick (Abstract). The dipstick, when presented with target nucleic acids, will produce a colored line for visual detection via hybridization of the target nucleic acids to colored anti-hapten detection conjugates (Figure 2). The target nucleic acids also bind to a capture probe. Lee teaches that the dipstick assay takes place in a cartridge that is placed into a machine for simplicity and ease of use (Figure 1 and page S69, column 1, para. 1).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the detection methods of Lee and Miick, in view of Tanabe, in view of Zhou, and in view of Moghaddam. Specifically, this would involve keeping the capture probes of Miick and using them in conjunction with the dipstick, cartridge, and machine of Lee to detect HCV in a sample. MPEP 2143 I (A) states, “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” Capture probes and the chromatographic dipstick assay were both known in the art, as evidenced by Miick and Lee, and their combination would not change the function of either element – it would simply result in being able to detect HCV with the assay instead of HIV. Thus, the results of this combination would be predictable. Additionally, Lee teaches that used of their dipstick assay “does not require expensive or complex instrumentation and is therefore intended to be affordable for routine use in resource-poor settings.” Therefore, this assay is easy to use, cheaper, and more easily accessible than other nucleic acid-based tests (page S66, column 1, para. 3), motivating the ordinary artisan to use this assay over other methods
Therefore, claim 12 is prima facie obvious over Miick, in view of Tanabe, in view of Zhou, in view of Moghaddam, and further in view of Lee.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Miick et al. (US 2018/0291474 A1), in view of Tanabe et al. (US 8,008,045 B2), in view of Zhou et al. (CN 106282404 A) and in view of Moghaddam et al. (Journal of Viral Hepatitis, 2006), in view of Kohara et al. et al. (US 6,201,166 B1), and further in view of Lee et al. (The Journal of Infectious Diseases, 2010).
Regarding claim 40, Miick, in view of Tanabe, in view of Zhou, in view of Moghaddam, and further in view of Kohara teaches the method of claim 9, as described above. Miick also teaches the use of capture probes that can be provided along with amplification oligomers (paras. 16 and 115).
However, none of these references teach that capture and/or detection can occur via a chromatographic dipstick assay.
Lee teaches an amplification-based assay for visually detecting HIV using a dipstick (Abstract). The dipstick, when presented with target nucleic acids, will produce a colored line for visual detection via hybridization of the target nucleic acids to colored anti-hapten detection conjugates (Figure 2). The target nucleic acids also bind to a capture probe. Lee teaches that the dipstick assay takes place in a cartridge that is placed into a machine for simplicity and ease of use (Figure 1 and page S69, column 1, para. 1).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the detection methods of Lee and Miick, in view of Tanabe, in view of Zhou, in view of Moghaddam, and further in view of Kohara. Specifically, this would involve keeping the capture probes of Miick and using them in conjunction with the dipstick, cartridge, and machine of Lee to detect HCV in a sample. MPEP 2143 I (A) states, “The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” Capture probes and the chromatographic dipstick assay were both known in the art, as evidenced by Miick and Lee, and their combination would not change the function of either element – it would simply result in being able to detect HCV with the assay instead of HIV. Thus, the results of this combination would be predictable.
Therefore, claim 40 is prima facie obvious over Miick, in view of Tanabe, in view of Zhou, in view of Moghaddam, in view of Kohara, and further in view of Lee.
Conclusion
No claims are currently allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/F.F.G./Examiner, Art Unit 1681
/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681