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 .
Claim Objections
Claim 13 is objected to because of the following informalities:
Re claim 13, line 2: substitute “SPME” with -- Solid-phase microextraction (SPME) --.
Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see page 7, 2nd to last paragraph of Remarks, filed 05/09/2025, with respect to the rejection(s) of claim(s) 13 under 35 U.S.C. @ 102(a) (1) have been fully considered and are persuasive (i.e., Huh does not discloses the newly amended SPME Polysorbate 80). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Huh et al. (US 2011/0129846 Al) and Zhang et al. (US 20160266083 A1).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “an evanescent wave-based fiber-optic wave guide fluorescent sensor. The competitive binding of target and cDNA with aptamer immobilized on the fiber surface enables the detection of targets in a signal-off mode.” (Remarks, p. 7, last paragraph), thickness of SPME (Remarks, p. 8, 1st paragraph), tuning the sensitivity and dynamic range of the detection by simply changing the SPME material or the fiber was coated with Tween 80 (Remarks, p. 8, 2nd paragraph), and aptamers with whole binding sequences (Remarks, page 8, 3rd paragraph)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is further reminded that the current claims 13-14 are directed to “a fiber-optic wave guide sensor of aptamers,” which is a device NOT method. As admitted by Applicant, on page 5, last paragraph of the Remarks, “SPME is a type of extraction technology,” which is a method. It has been held that “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard Co. v. Bausch & Lomb Inc. 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)); that a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all of the structural limitations of the claim (Ex parte Masham, 2 USPQ 2d 1647 (Bd. Pat. App. & Inter. 1987)); and that if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)). See MPEP § 2111.02, II and MPEP § 2114, II.
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20160266083 A1).
Regarding claim 13, Zhang et al. discloses an optic sensor of aptamers ([0022] and [0042]), combining SPME [0024] and aptamers ([0042] and [0047]), synchronously assembling extraction layer SPME [0024] and aptamers having target specificity (inherent – each aptamer should have a target specificity) on a fiber-optic sensing interface, said extraction layer SPME being Polysorbate 80 [0024].
Zhang et al. is silent with respect to said target comprising at least one of kanamycin A of hydrophilic small molecule antibiotic, sulfadimethoxine of hydrophobic small molecule antibiotic, Alternariol of small molecule mycotoxin, and Di-(2-ethylhexyl) phthalate of high hydrophobic small molecule. Haick et al. discloses a fiber-optic wave guide sensor (col. 13, lines 1-3) of aptamers having SPME fiber (col. 12, lines 63-67).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the target comprising at least one of the claimed materials since choosing a target material is merely an intended use. Therefore, such modification would have been an obvious design variation, well within the ordinary skill in the art, since it has been held that the selection of a known material based on its suitability for its intended use. In re Leshin, 125 USPQ 146. Further, when the structure recited in the reference is substantially identical to that of the claims, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (MPEP 2112.01 [R-07.2015]). The patentability of a product depends only on the claimed structural limitations of the product and must be distinguished structurally. Zhang et al. discloses an optic sensor having both SPME layer/ Polysorbate 80 and aptamers that is substantially identical to that of the claimed invention, therefore the claimed properties or functions are presumed to be inherent or obvious. The burden is on the applicant to show that the prior art device does not possess the claimed properties or is not capable of these functional characteristics. (See MPEP 2112.01).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20160266083 A1) in view of Huh et al. (US 2011/0129846 A1).
Regarding claim 14, Zhang et al. discloses the fiber-optic wave guide sensor of aptamers of claim 13, but fails to teach said aptamers having target specificity being tethered on a fiber surface.
Huh et al. discloses the fiber-optic wave guide sensor of aptamers (Fig. 4) of claim 13, said aptamers being tethered on the fiber surface (500, Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the aptamers being tethered on the fiber surface as taught by Huh et al. since tethering aptamers to a fiber optic for SPME based small-molecule detection is well-known in the prior art and one of ordinary skill could have combined the elements by known coupling methods with no change in their respective functions to yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Zhang et al. in view of Huh et al. fails to explicitly disclose aptamers having target specificity being NH2-(EG)18-TGGGGGTTGAGGCTAAGCCGAGTCACTAT (SEQ ID NO. 1), or NH2-(EG)18-GAGGGCAACGAGTGTTTATAGA (SEQ ID NO. 2), or NH2-(EG)18-CTTTCTGTCCTTCCGTCACATCCCACGCATTCTCCACAT (SEQ ID No. 3), or NH2-AAAAAAAAAATAGCTTAACTAGTGTTCAAGCTG (SEQ ID N0. 12).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the target comprising at least one of the claimed materials since choosing a target material is merely an intended use. such modification would have been an obvious design variation, well within the ordinary skill in the art, since it has been held that the selection of a known material based on its suitability for its intended use. In re Leshin, 125 USPQ 146. Further, when the structure recited in the reference is substantially identical to that of the claims, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (MPEP 2112.01 [R-07.2015]) The patentability of a product depends only on the claimed structural limitations of the product and must be distinguished structurally. Zhang et al. discloses an optic sensor having both SPME layer/ Polysorbate 80 and aptamers that is substantially identical to that of the claimed invention, therefore the claimed properties or functions are presumed to be inherent or obvious. The burden is on the applicant to show that the prior art device does not possess the claimed properties or is not capable of these functional characteristics. (See MPEP 2112.01).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haick et al. (US 8945935 B2) and Barth et al. (WO 2020076330 A1) disclose an optical sensor having SPME fiber.
Murray (US 20030003587 A1) discloses an optical sensor using solid phase micro-extraction to preconcentrate organic compounds prior to chromatographic analysis.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Uyen-Chau N. Le whose telephone number is (571)272-2397. The examiner can normally be reached Monday-Friday, 9:00am-5:30pm.
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/UYEN CHAU N LE/ Supervisory Patent Examiner, Art Unit 2874
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