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
2. This Office Action is responsive to Applicant’s Amendment and Remarks, filed December 9, 2025. The amendment, filed December 9, 2025, is entered, wherein claims 1, 44, and 47 are amended, claims 2 – 4, 7, 9, 16, 18 – 20, 22 – 31, 33 – 40, 42 – 43, and 45 – 46 are canceled, claims 13 – 15, 17, 21, 32, 41, and 48 are withdrawn, and claim 50 is new.
Claims 1, 5 – 6, 8, 10 – 12, 44, 47, and 49 – 50 are examined on the merits herein.
Priority
The application is a 371 of PCT/US2019/046912, filed August 16, 2019, which claims benefit of domestic application 62/765,149, filed August 17, 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/06/2025 and 01/28/2026 were filed after the mailing date of the previous Office Action on September 11, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
5. The objection of claim 47 in the previous Office Action, mailed September 11, 2025, is withdrawn in view of the amended claim 47.
Withdrawn Rejections
6. The rejection of claims 4 and 7 in the previous Office Action, mailed September 11, 2025, under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends has been considered and is withdrawn in view of the canceled claims 4 and 7.
The rejection of claims 1, 10 – 12, 44, and 47 in the previous Office Action, mailed September 11, 2025, under 35 U.S.C. 103 as being unpatentable over Fellah in view of Guillotin et al. has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 4 – 8 in the previous Office Action, mailed September 11, 2025, under 35 U.S.C. 103 as being unpatentable over Fellah in view of Guillotin et al., and further in view of Lenucci et al. has been considered and is withdrawn in view of the amended claim 1.
The rejection of claim 49 in the previous Office Action, mailed September 11, 2025, under 35 U.S.C. 103 as being unpatentable over Fellah in view of Guillotin et al. and Lenucci et al., and further in view of Brown has been considered and is withdrawn in view of the amended claim 1.
The following are new grounds of rejection necessitated by Applicant’s Amendment and Remarks, filed December 9, 2025, wherein claims 1, 44, and 47 are amended, claims 2 – 4, 7, 9, 16, 18 – 20, 22 – 31, 33 – 40, 42 – 43, and 45 – 46 are canceled, claims 13 – 15, 17, 21, 32, 41, and 48 are withdrawn, and claim 50 is new. Previously cited references have been used to establish the new grounds of rejection.
New Claim Objections
Claims 1, 44, and 50 are objected to because of the following informalities:
Claim 1, lines 13 and 17, “selected” should be inserted immediately after “integer”.
Claim 1, line 14, “is” should be removed immediately after “independently”.
Claim 44, lines 12 and 16, “selected” should be inserted immediately after “integer”.
Claim 44, line 13, “is” should be removed immediately after “independently”.
Claim 50, lines 13 and 17, “selected” should be inserted immediately after “integer”.
Claim 50, line 14, “is” should be removed immediately after “independently”.
Appropriate correction is required.
New 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:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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, 10 – 11, 44, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (Journal of Chromatography A, 2014, Vol. 1345, page 57 – 67, Reference included with PTO-892) with evidence provided by Vitre (University of Southampton, 2003, Reference included with PTO-892) in view of Synytsya et al. (Czech Journal of Food Science, 2003, Vol. 21, Issue 5, page 162 – 166, Reference included with PTO-892).
Regarding claims 1, 10 – 11, 44, and 47, Sheng et al. teach a dextran-bonded stationary phase for saccharide separation (Title). The stationary phase contains high molecular polysaccharide that is chemically bonded and immobilized on the silica (Abstract). The main characteristic of the HILIC stationary phase is that the polar group, such as hydroxyl group, on its surface has affinity for water. In recent years, new separation materials have been generated that mainly contain strong polar molecules, such as carbohydrate bonded to silica (page 57, Left Col. Para. 1). The dextran-bonded materials not only display the performance in isolation and analysis in glycobiology, but also have potential application in glycopeptide analysis in glycoproteomics (page 58, Left Col., para. 2). Sheng et al. disclose the dextran-bonded stationary phase with the following structure (page 59, Fig. 1):
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,
wherein
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,
which shows the dextran is bonded to the solid support via amide moiety. The dextran used has a molecular weight of 20,000 Da and the spherical silica has a particle size of 5 μm (page 58, Left Col., para. 3).
However, Sheng et al. do not teach the solid support comprising modified pectin molecules.
Synytsya et al. teach preparing N-alkylpectinamides:
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by aminolysis of high methylated citrus pectin using N-alkylamines including N-butylamine, N-hexylamine, N-octylamine, N-dodecylamine, and n-octadecylamine (page 163, Right Col., para. 3). This chemical modification is relatively easy and it modifies the physiochemical and biological properties of the pectin in a significant way (page 162, Right Col., para. 2; page 163, Left Col., para. 1). Synytsya et al. disclose that these modified pectin may be used as bioavailable sorbents (page 165, Right Col., para. 2).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. as an alternative for high molecular polysaccharide because it is known in the art that pectin is a high molecular polysaccharide, Sheng et al. teach that strong polar molecules, such as carbohydrate, are desired when generating new separation materials. One would have been motivated to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. because Sheng et al. suggest that separation materials may be a carbohydrate with polar groups, such as hydroxyl, on the surface and Synytsya et al. disclose the amidated pectin that is a high molecular carbohydrate with some hydroxyl groups, which provides strong polar groups that are desirable, and the modified pectin may be used as sorbents. It is expected that the modified pectin will covalently bonded to the solid support via the amide moiety because Vitre discloses that the molecules to be conjugated are bound to the solid support via linker and the linker attachment is traditionally an amide bond (page 3, para. 1). For the molecular weight of pectin, one would have considered the molecular weight of dextran used in the stationary phase and would have performed routine experimentation to discover the best molecular weight of pectin for optimal separation characteristics. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. as an alternative for high molecular polysaccharide because Sheng et al. disclose a dextran-bonded solid support and suggests that materials that is a high molecular carbohydrate may be used in separation and Synytsya et al. teach the amidated pectin that may be used as a sorbent.
Claims 5 – 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (Journal of Chromatography A, 2014, Vol. 1345, page 57 – 67, Reference included with PTO-892) with evidence provided by Vitre (University of Southampton, 2003, Reference included with PTO-892) in view of Synytsya et al. (Czech Journal of Food Science, 2003, Vol. 21, Issue 5, page 162 – 166, Reference included with PTO-892) as applied to claims 1, 10 – 11, 44, and 47 above, and further in view of Lenucci et al. (Phytochemistry, 2005, Vol. 66, Issue 21, page 2581 – 2594, cited in the previous Office Action mailed April 18, 2025).
Regarding claims 5 – 6 and 8, the references teach the limitations discussed above.
However, these references do not explicitly teach the amidated pectin comprises one or more units represented by
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or an isomer, a salt, a tautomer, or a combination thereof, as in claim 8. The references also do not explicitly teach the amidated pectin is a pectin amidated with a C4-C20 polyamine, wherein the polyamine is putrescine, spermine, or spermidine, as in claims 5 and 6.
Lenucci et al. teach that pectins are polyanionic and are potentially neutralized by other cations such as polyamines. Some studies have reported the presence of ionically bound polyamines in pectic fractions. The three main polyamines are putrescine, spermidine, and spermine. Polyamines are powerful modulators of the supramolecular conformation of pectins (page 2582, Left Col., para. 2). Lenucci et al. also disclose that pectin and polyamine can form covalent amide bond (page 2582, Left Col., para. 3). The structure of N-D-galacturonoyl-putrescinamide (MGP), a polyamine-incorporated pectin, is shown below (Figure 1):
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.
Lenucci et al. teaches any pectin-linked Spd and Spm as well as Put moieties (page 2586, Left Col., para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin or polyamine-modified pectin, such as pectin-putrescine (or pectin-spermine or pectin-spermidine) in view of Synytsya et al. and Lenucci et al. because Sheng et al. teach immobilized carbohydrate polymers on silica for separation based on the polar groups on the surface, Synytsya et al. teach that amidated pectin may be used as sorbent, and Lenucci et al. teach amidated pectin derivatives that would predictably provide strong polar property. One would have been motivated to substitute the dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin or polyamine-modified pectin, such as pectin-putrescine (or pectin-spermine or pectin-spermidine) in view of Synytsya et al. and Lenucci et al. because Sheng et al. suggest that separation materials may be strong polar molecules that are carbohydrate, Synytsya et al. teach that amidated pectin may be used as sorbent, and Lenucci et al. disclose the structure of polyamine-modified pectin that is a carbohydrate with amide moiety, which provides strong polar groups that are desirable. Pectin-spermidine taught by Lenucci et al. reads on the structure:
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recited in claim 8. Therefore, a person of ordinary skill in the art would have had a reasonable expectation of success to substitute the dextran in the dextran-bonded stationary phase as taught by Sheng et al. with amidated pectin or polyamine-modified pectin, such as pectin-putrescine (or pectin-spermine or pectin-spermidine) in view of Synytsya et al. and Lenucci et al. because Sheng et al. disclose a dextran-bonded solid support and suggests that materials that is a high molecular carbohydrate may be used as separation materials, Synytsya et al. teach that amidated pectin may be used as a sorbent, and Lenucci et al. teach that polyamine-modified pectin containing multiple amine and amide moieties is a strong polar high molecular polysaccharide.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (Journal of Chromatography A, 2014, Vol. 1345, page 57 – 67, Reference included with PTO-892) with evidence provided by Vitre (University of Southampton, 2003, Reference included with PTO-892) in view of Synytsya et al. (Czech Journal of Food Science, 2003, Vol. 21, Issue 5, page 162 – 166, Reference included with PTO-892) as applied to claims 1, 10 – 11, 44, and 47 above, and further in view of Takeuchi et al. (Chromatographia, 1988, Vol. 25, Issue 4, page 332 – 334, Reference included with PTO-892)
c. Regarding claim 12, the references teach the limitations discussed above.
However, these references do not teach the solid of the solid support is a glass bead.
Takeuchi et al. disclose a study on evaluating porous glass bead as the stationary phase (Summary). The retention behavior of the glass column is very similar to that of the silica gel column (page 334, Left Col., para. 1).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the silica as taught by Sheng et al. with glass bead in view of Takeuchi et al. because Takeuchi et al. disclose the results comparing silica and glass and demonstrate that silica and glass behave similarly in chromatography. It would have been obvious for one of ordinary skill in the art to do this because both materials are known separately in the prior art for the purpose of stationary phase, and it would have been obvious to substitute equivalent materials for the same purpose. One of ordinary skill in the art would have had a reasonable expectation of success to substitute silica as taught by Sheng et al. with glass bead in view of Takeuchi et al. because it is known in the art to substitute known alternatives for the same purpose.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (Journal of Chromatography A, 2014, Vol. 1345, page 57 – 67, Reference included with PTO-892) with evidence provided by Vitre (University of Southampton, 2003, Reference included with PTO-892) in view of Synytsya et al. (Czech Journal of Food Science, 2003, Vol. 21, Issue 5, page 162 – 166, Reference included with PTO-892) as applied to claims 1, 10 – 11, 44, and 47 above, and further in view of Brown (Wiley-Vch, Cop, 2012, cited in the previous Office Action).
d. Regarding claim 49, the references teach the limitations discussed above. However, these references do not teach that R3 is CH3.
Brown teaches that -CH3 is a classical bioisosteres of -H (page 17, 2.3.1 Monovalent Atoms and Groups).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the hydrogen bonded to N in the modified pectin by aminolysis:
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as taught by Synytsya et al with -CH3 in view of Brown because Brown teaches that -CH3 is a classical bioisostere of H. This substitution will yield to predictable results. Therefore, a person of ordinary skill in the art would have had a reasonable expectation of success to substitute the hydrogen bonded to N in the modified pectin by aminolysis:
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as taught by Synytsya et al with -CH3 as in view of Brown because Synytsya et al. teach that pectin may be modified by aminolysis and Brown teaches that the substitution of H with CH3 is known in the art, which yields predictable results. Furthermore, as set forth in MPEP § 2144.08 (II) 4(b) – (e), methyl is obvious over H at the recited position because it is the selection of a structurally similar species from the disclosed genus in view of the prior art and a reasonable expectation of similar properties and predictable results.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (Journal of Chromatography A, 2014, Vol. 1345, page 57 – 67, Reference included with PTO-892) with evidence provided by Vitre (University of Southampton, 2003, Reference included with PTO-892) in view of Synytsya et al. (Czech Journal of Food Science, 2003, Vol. 21, Issue 5, page 162 – 166, Reference included with PTO-892), and Sandetskaya et al. (Future Science OA, 2017, Vol. 3, Issue 2, Reference included with PTO-892).
e. Regarding claim 50, Sheng et al. teach a dextran-bonded stationary phase for saccharide separation (Title). The stationary phase contains high molecular polysaccharide that is chemically bonded and immobilized on the silica (Abstract). The main characteristic of the HILIC stationary phase is that the polar group, such as hydroxyl group, on its surface has affinity for water. In recent years, new separation materials have been generated that mainly contain strong polar molecules, such as carbohydrate bonded to silica (page 57, Left Col. Para. 1). The dextran-bonded materials not only display the performance in isolation and analysis in glycobiology, but also have potential application in glycopeptide analysis in glycoproteomics (page 58, Left Col., para. 2). Sheng et al. disclose the dextran-bonded stationary phase with the following structure (page 59, Fig. 1):
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wherein
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which shows the dextran is bonded to the solid support via amide moiety. Sheng et al. evaluate the stationary phase and demonstrate the retention behavior for multiple nucleobases/nucleosides, such as uracil and uridine, and describe the stability under elution conditions (page 60, Left Col, para. 2 – 3; Figures 3 – 4).
However, Sheng et al. do not teach the solid support comprising modified pectin molecules. Sheng et al. do not teach a cartridge for nucleic acid and detection, wherein the cartridge comprises a plurality of processing chambers for lysis and purification of nucleic acid, a solid support, a reaction tube for amplification, and fluidic path.
Synytsya et al. teach preparing N-alkylpectinamides:
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by aminolysis of high methylated citrus pectin using N-alkylamines including N-butylamine, N-hexylamine, N-octylamine, N-dodecylamine, and n-octadecylamine (page 163, Right Col., para. 3). This chemical modification is relatively easy and it modifies the physiochemical and biological properties of the pectin in a significant way (page 162, Right Col., para. 2; page 163, Left Col., para. 1). Synytsya et al. disclose that these modified pectin may be used as bioavailable sorbents (page 165, Right Col., para. 2). Sandetskaya et al. teach an integrated versatile lab-on-a-chip platform for the isolation and nucleic acid detection (Title). The cartridge:
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comprises different chambers for lysis, DNA amplification, and real-time detection. In one embodiment, lysis may be performed in compartment 4 outside of the amplification chamber, while DNA can be transferred using magnetic beads to the latter through the washing chambers 5 and 6 (page 3, Right Col., para. 2 – 3). In the full version of the assay, the chip integrates lysis, DNA purification, amplification, and detection all together with stationary microfluidics (page 9, Right Col., para. 2; page 10, Left Col., para. 1).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. as an alternative for high molecular polysaccharide because it is known in the art that pectin is a high molecular polysaccharide, Sheng et al. teach that strong polar molecules, such as carbohydrate, are desired when generating new separation materials. One would have been motivated to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. because Sheng et al. suggest that separation materials may be a carbohydrate with polar groups, such as hydroxyl, on the surface and Synytsya et al. disclose the amidated pectin that is a high molecular carbohydrate with some hydroxyl groups, which provides strong polar groups that are desirable, and the modified pectin may be used as sorbents. It is expected that the modified pectin will covalently bonded to the solid support via the amide moiety because Vitre discloses that the molecules to be conjugated are bound to the solid support via linker and the linker attachment is traditionally an amide bond (page 3, para. 1). For the molecular weight of pectin, one would have considered the molecular weight of dextran used in the stationary phase and would have performed routine experimentation to discover the best molecular weight of pectin for optimal separation characteristics. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to substitute dextran in the dextran-bonded stationary phase as taught by Sheng et al. with the amidated pectin in view of Synytsya et al. as an alternative for high molecular polysaccharide because Sheng et al. disclose a dextran-bonded solid support and suggests that materials that is a high molecular carbohydrate may be used as separation materials and Synytsya et al. teach the amidated pectin that may be used as a sorbent.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the solid support comprising amidated pectin that is covalently bonded to and coated on the solid of the solid support via amide bond as taught by Sheng et al. and Synytsya et al. with the cartridge for nucleic acid isolation and detection in view of Sandetskaya et al. because Sheng et al. demonstrate that the polysaccharide-based solid support exhibits retention for polar analytes, such as nucleobase or nucleoside. One would have been motivated to incorporate the solid support comprising amidated pectin that is covalently bonded to and coated on the solid of the solid support via amide bond as taught by Sheng et al. and Synytsya et al. with the cartridge for nucleic acid isolation and detection in view of Sandetskaya et al. because Sheng et al. demonstrate strong retention behavior for nucleic acid related polar compounds, such as nucleobase or nucleosides, which provides evidence that polysaccharide-based silica is suitable for such analytes. One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the solid support comprising amidated pectin that is covalently bonded to and coated on the solid of the solid support via amide bond as taught by Sheng et al. and Synytsya et al. with the cartridge for nucleic acid isolation and detection in view of Sandetskaya et al. because Sheng et al. teach that polysaccharide-based solid support with the amide moiety exhibits retention for nucleic acid related polar molecules.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed December 9, 2025, have been fully considered and are found to be not persuasive.
Regarding Fellah, Applicant argues that Fellah fails to teach amidated pectin and Fellah teaches the immobilization of pectins onto pre-aminated bead via reductive amination or thiazolidine. Applicant further argues that Fellah teaches the structure of the solid support that has the pectins attached to the support via pyranose ring instead of attaching via the amide moieties.
Regarding Guillotin et al., Applicant argues that Guillotin et al. fails to cure the deficiencies of Fellah because Guillotin et al. do not teach or suggest the covalent bonding of the claimed amidated pectins to the solid support. Applicant argues that the combination of Fellah and Guillotin et al. fails to provide a teaching of how one of skill would take Fellah and modify it such that it could be used to attach Guillotin’s amidated pectin at the amide moiety. Finally, Applicant argues that none of the additional references teaches the deficiencies of Fellah and Guillotin regarding the covalent bonding of such pectins to solid substrates. However, the arguments are moot because the new rejection is based on Sheng et al. and Synytsya et al. Sheng et al. teach a high molecular polysaccharide solid support, such as dextran-based with amide linkage between the polysaccharide and the support and Sheng et al. suggest that other separation materials that is a carbohydrate and amide might be used. Synytsya et al. teach amidated pectin that is a high molecular polysaccharide with amide moiety and the amidated pectin may act as sorbent. It would have been obvious to substitute because it is known in the art that pectin is a high molecular polysaccharide, Sheng et al. teach that strong polar molecules, such as amide and carbohydrate, are desired when generating new separation materials, and Synytsya et al. teach amidated pectin that may act as sorbent. Therefore, the combination of Sheng et al. and Synytsya et al. renders the claimed invention obvious.
Conclusion
No claim is found to be allowable.
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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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693