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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/17/26 has been entered.
Information Disclosure Statement
The information disclosure statement filed 06/17/26 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Response to Amendment
Applicant’s remark and amendment filed on 06/17/26 have been entered. Claims 1, 4, 5, 7, 11, 14, 17-19, 24, -26, 34, 37, 40-44, 48, 50, 58-60 remain pending. Claim 47 is cancelled. Claim 60 is added. Claims 40-44, 48, and 50 remain withdrawn. Claims 1, 4, 5, 7, 11, 14, 17-19, 24, -26, 34, 37, and 58-60 are examined herein. Applicant’s amendment and remark have overcome each and every rejection set forth in the previous Office Action.
Status of Rejection
The rejection of claim 40 is obviated by Applicant’s cancellation.
The rejection of claims 34 and 37 under 112(b) is withdrawn in view of Applicant’s amendment.
The rejection of claims 1, 4, 5, 7, 11, 14, 17-19, 24, -26, 34, 37, and 58-29 under 102 and 103 in view of Manning (US 20140311985 A1) is withdrawn in view of Applicant’s remark. Upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation Manning.
Response to Arguments
Applicant’s arguments, see page 9, para. 2 in section Claim Rejections Over Manning, filed 06/17/26, with respect to the rejection(s) of claim(s) 1, 14, 25, 26, 34, and 58 under 102(a)(1) have been fully considered and are persuasive.
The traversal is on the ground that Office’s mapping of spring 81 of Manning (US 20140311985 A1), cited in previous Office Action, to the claimed second seal incorrect as Manning does not disclose of the spring being a seal, let alone being adapted to seal an internal cavity as claimed (page 9, Claim Rejections Over Manning, para. 2). This is determined to be persuasive.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Manning. Examiner believes the new mapping of the filament lock mechanism 80 of Manning to the claimed second seal would have taught the claim limitation.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 14, 25, 26, 34, 58, and 60 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manning (US 20140311985 A1).
Regarding claim 1, Manning discloses a device adapted to prepare a sample for testing, the device comprising:
a sealed container (instrument 30, Figure 2A) comprising an opening adapted to receive a solid sample (the opening of instrument 30 for housing filament 20, Fig. 2) and a reservoir adapted to receive the solvent (the interior of the instrument); and
a valve (Device highlighted in 10, Figure 2) coupled to the container (Fig. 2), the valve comprising:
a slidable holder (Fig. 6) defining an internal cavity (interior of filament 20), the slidable holder adapted to transition between a first sealed configuration and a second open configuration (See below),
a first seal (Shoulder ring 88, Fig. 14) disposed at a first end of the holder, the first seal adapted to seal the cavity from the reservoir in the first sealed configuration (The locking mechanism depicted in FIG. 14 comprises a shoulder ring 88 that engages with an extended shoulder 82 of an instrument 30. When the filament 20 is retracted the shoulder ring can move past the collar 82, to allow the device to engage and disengage with the instrument 30 (e.g., through flexing or bending of the shoulders along the shoulder ring 88). Para. [0055]) and to be displaced within the reservoir in the second open configuration (interpreted to be the process of filament 20 in fluidic communication with instrument 30) to place the internal cavity in fluid communication with the reservoir (a coated or uncoated fiber (filament) housed within a needle of a syringe is brought into contact with components/analytes in a fluid carrier or headspace above the carrier for a sufficient period of time for extraction of the analytes to occur onto the fiber or coated fiber (para. [0004]),
a plunger adapted to move longitudinally (stepper mechanism 50, Fig. 10) within the slidable holder between a first plunger sealed configuration and a second plunger sample configuration (See below), and a second seal (filament lock 80, Fig. 10) coupled to the plunger and adapted to seal the internal cavity from a sample port (filament 20, Fig. 10) in a first plunger sealed configuration (When the pressure is released, the filament 20 withdraws into the device. However, if, while the filament 20 is extended, the filament lock 80 is engaged, the filament 20 is held in the extended conformation (e.g., for filament cleaning, for sample loading, etc.)…To prevent the filament lock 80 from engaging while the filament 20 is inserted into an instrument, engagement of the filament lock 80 is physically incompatible with engagement of the SPME device with an instrument. A locked SPME cannot engage with an instrument and an instrument-engaged SPME device cannot become locked.; para. [0049]) and to retract within the holder to place the internal cavity in fluid communication within the sample port in the second plunger sample configuration (When the filament lock 80 is disengaged, and in the absence of downward pressure on the housing 10, the filament 20 withdraws into the SPME device. para. [0049]).
The limitations regarding the opening adapted to receive a solid sample and reservoir adapted to receive a solvent; and the reservoir being adapted to provide for the concentrate to be settled into a solvent layer within the container; and the valve adapted to receive a sample of the concentrate from within the solvent layer are recitation of intended use.
Manner of operating an apparatus does not differentiate apparatus claim from the prior art. 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 the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 14, Manning discloses the claimed invention as discussed above in claim 1. Manning discloses the sample port comprising a dispensing tip (filament 20, Fig. 2, 6, and 10) disposed on a bottom of the sealed container (Figure 2 when the SPME device is engaged with the instrument 30).
Regarding claim 25, Manning discloses the claimed invention as discussed above in claim 1. The limitation is interpreted as recitation of intended use as the analysis chamber is not part of the claimed invention. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. 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 the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 26, Manning discloses the claimed invention as discussed above in claim 1. Manning discloses the container comprises a vessel (Instrument 30, Fig. 2). The limitation of vessel adapted to settle the concentrate into the solvent layer is interpreted as recitation of intended use as the ability of concentrate settling into a solvent layer is dependent on the properties of the sample and solvent used, which are not positively recited as part of the claimed device, rather than the property/ability of the vessel itself. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. 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 the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 34, Manning discloses a device adapted to prepare a sample for testing, the device comprising:
a receptacle (interpreted as the cavity of instrument 30 for receiving and engaging with the device 10, Figure 2);
a liquid chamber (instrument 30, Figure 2A); and
a valve (Device highlighted in 10, Figure 2) coupled to the container (Fig. 2), the valve comprising:
a slidable holder (Fig. 6) defining an internal cavity (interior of filament 20), the slidable holder adapted to transition between a first sealed configuration and a second open configuration (See below),
a first seal (Shoulder ring 88, Fig. 14) disposed at a first end of the holder, the first seal adapted to seal the cavity from the reservoir in the first sealed configuration (The locking mechanism depicted in FIG. 14 comprises a shoulder ring 88 that engages with an extended shoulder 82 of an instrument 30. When the filament 20 is retracted the shoulder ring can move past the collar 82, to allow the device to engage and disengage with the instrument 30 (e.g., through flexing or bending of the shoulders along the shoulder ring 88). Para. [0055]) and to be displaced within the reservoir in the second open configuration (interpreted to be the process of filament 20 in fluidic communication with instrument 30) to place the internal cavity in fluid communication with the reservoir (a coated or uncoated fiber (filament) housed within a needle of a syringe is brought into contact with components/analytes in a fluid carrier or headspace above the carrier for a sufficient period of time for extraction of the analytes to occur onto the fiber or coated fiber (para. [0004]),
a plunger adapted to move longitudinally (stepper mechanism 50, Fig. 10) within the slidable holder between a first plunger sealed configuration and a second plunger sample configuration (See below), and a second seal (filament lock 80, Fig. 10) coupled to the plunger and adapted to seal the internal cavity from a sample port (filament 20, Fig. 10) in a first plunger sealed configuration (When the pressure is released, the filament 20 withdraws into the device. However, if, while the filament 20 is extended, the filament lock 80 is engaged, the filament 20 is held in the extended conformation (e.g., for filament cleaning, for sample loading, etc.)…To prevent the filament lock 80 from engaging while the filament 20 is inserted into an instrument, engagement of the filament lock 80 is physically incompatible with engagement of the SPME device with an instrument. A locked SPME cannot engage with an instrument and an instrument-engaged SPME device cannot become locked.; para. [0049]) and to retract within the holder to place the internal cavity in fluid communication within the sample port in the second plunger sample configuration (When the filament lock 80 is disengaged, and in the absence of downward pressure on the housing 10, the filament 20 withdraws into the SPME device. para. [0049]).
The limitations regarding the receptacle adapted to receive a solid sample and liquid chamber adapted to receive a solid sample with a solvent is interpreted to be recitation of intended use.
Manner of operating an apparatus does not differentiate apparatus claim from the prior art. 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 the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 58, Manning discloses the claimed invention as discussed above in claim 1. Manning discloses the plunger is biased in the first plunger sealed configuration (Figure 10 B) by a spring (spring 81, Fig. 10), and the plunger is adapted to transition to the second plunger sample configuration via applying force to the spring by pressing the plunger against a surface (Fig. 10 A).
Regarding claim 60, Manning discloses the claimed invention as discussed above in claim 1. Manning discloses the slidable holder comprises a spring clip (interlocking end 86 b, Fig. 12B) and the valve comprises a stop notch (recess portion of hook collar 85b, Fig. 12B), and wherein the spring clip is adapted to engage the stop notch to retain the slidable holder in the second open configuration (The flexible end 86 a of the sliding lock 86 holds the sliding lock in a position so as not to interfere with the movement of the hook collar 85 (SEE FIG. 12A). The locking mechanism has no substantive effect when the device is not engaged with an instrument. However, when the SPME device is engaged with an instrument, the interlocking end 86 b contacts the instrument 30 causing the sliding lock 86 to adopt an engaged position (SEE FIG. 12B). para. [0053]).
Claim Rejections - 35 USC § 103
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manning in view of Mashile (In-Syringe Micro Solid-Phase Extraction Method for the Separation and Preconcentration of Parabens in Environmental Water Samples, 2018).
Regarding claim 59, Manning discloses the claimed invention as discussed above in claim 1. Manning does not explicitly disclose the there is a desiccant or drying agent disposed within the internal cavity. It is known in the art that a micro solid-phase extraction syringe may comprise sorbent (interpreted as claimed desiccant or drying agent) within the syringe for moisture removal. In an analogous art, Mashile discloses a in-syringe micro-solid phase extraction device wherein the syringe is modified with a sorbent (Abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the interior of filament with sorbent as taught by Mashile. Doing so enhances separation of analyte from extracted fluid (Introduction, para. 5, Mashile).
Allowable Subject Matter
Claims 4, 5, 7, 11, 17-19, 24, and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, 7, 17, and 18, the closest prior art, Manning discloses the claimed invention as discussed above in claim 1. However, Manning does not disclose the solvent is disposed within an ampoule disposed within the container.
Manning discloses the container/instrument applicable to be used with the SPME device include analytical instrument such as mass spectrometer, gas chromatograph, infrared spectrometer (para. [0030]), none of which is known to store ampoules.
Regarding claims 4, 11, 19, and 37, the closest prior art discloses the claimed invention as discussed above in claims 1 and 34. Manning does not disclose the claimed feature of the container/instrument in claims 4, 11, 19, and 37.
The second closest art, Fischer (US 4568331 A; cited in previous OA), discloses a device adapted to prepare a sample for testing, the device (Figure 4) comprising:
a sealed container (12, Fig. 1-4) comprising an opening adapted to receive a solid sample (end 16, fig. 1 and 3) and a reservoir comprising a solvent or adapted to receive the solvent (interior of chamber 12, Fig. 1,2, and 4), wherein the sealed container comprises first seal (cap 18, Fig. 1, 3, and 4) and a second seal (clamp 26, Fig. 1-4) disposed in two locations and the first seal is accessible for receiving the solid sample as a tablet sample or an undivided solid sample (the opening 16 is configured to receive both solid and liquid) and the second seal is accessible for sampling the concentrate (clamp 26 is sealing tube 24). Furthermore, sealed container is adapted to facilitate crushing the pill through a wall of the container (Col. 3, Lines 55-64; also see Fig. 2).
As the device of Manning is designed for analytical instrument such as mass spectrometer, gas chromatograph, infrared spectrometer (para. [0030]), one of ordinary skill in the art would not have utilized the device of Fischer to cure the deficiency of Manning.
Regarding claim 24, Manning discloses the claimed invention as discussed above in claim 1. Manning does not disclose the claimed feature of claim 24.
The second closest art, Hagstrom (US 5800782 A; cited in previous OA), discloses a device adapted to prepare a sample for testing, the device (Figure 2-4) comprising:
a sealed container (Fig. 2-4) comprising an opening adapted to receive a solid sample (mouth 22a and 32a, fig. 2-3) and a reservoir comprising a solvent or adapted to receive the solvent (interior of reaction container 22, 32 Fig. 2, and 3), wherein the sealed container comprises a mixing chamber (reaction container 22, 23, Fig.2-3) and a separatory chamber (filter funnel 48, Fig. 4), wherein a seal (funnel mouth 48a, Fig. 4) in the sealed container is adapted to facilitate delivering the mixed liquid to the separatory chamber for settling (Col. 10, Lines 48-62).
As the device of Manning is designed analytical instrument such as mass spectrometer, gas chromatograph, infrared spectrometer (para. [0030]), one of ordinary skill in the art would not have utilized the device of Hagstrom to cure the deficiency of Manning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
