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 .
Election/Restrictions
Applicant’s election without traverse of species A in the reply filed on 11/24/25 is acknowledged.
Claim 8 is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6 recites, “wherein the charged droplets of the solvent comprising the analyte from the sample are emitted from the first end of the capillary and are then drawn into the one or more sampling conduits without impacting the sample.”
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed.
While there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc).
In the case at hand, the claim defines the invention with functional language specifying a desired results, namely, “the charged droplets of the solvent comprising the analyte from the sample are emitted from the first end of the capillary and are then drawn into the one or more sampling conduits without impacting the sample.” However, nowhere in the disclosure is there any discussion as to how droplets of solvent comprising analyte can be obtained without the droplets impacting the sample. Rather, the disclosure offers a description of how droplets of solvent gain sample analyte by contacting, i.e., impacting, said sample. The disclosure also explains that droplets of solvent may be emitted directly from the capillary into the sampling conduit, but does not specify that such droplets include any sample analytes at all. Since the disclosure does not explain how one might obtain charged droplets of the solvent comprising the analyte from the sample without impacting the sample, one of ordinary skill in the art would not recognize that the applicant had possession of the claimed invention. Further, since one of ordinary skill in the art would not recognize that the applicant had possession of the claimed invention, the claim is rejected for failing the written description requirement.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 7, 11-17, 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018189533A1 [Jones].
Regarding Claim 1:
Jones teaches a method of analysing a sample (1:12-14), the method comprising:
providing a capillary having an outlet at a first end (Fig. 2a (10));
supplying a flow of solvent to the capillary such that solvent is emitted from the outlet of the capillary (Fig. 2a (24), 7:9-14, 15:16-22);
bringing the sample and the first end of the capillary into contact with, or proximate to, each other such that analyte from the sample is absorbed by solvent emitted from the outlet of the capillary (As shown in Fig. 4, 15:34-35);
applying a voltage to the solvent such that charged droplets of the solvent comprising the analyte from the sample are emitted from the first end of the capillary (7:32-31); and
causing the charged droplets to be drawn into one or more sampling conduits connected to an atmospheric interface of an analytical instrument (Fig. 2a (11), 15:34-16:3).
Regarding Claim 2:
Jones teaches the method of claim 1, wherein the capillary is housed by a housing that forms a handle. As shown in Fig. 6B.
Regarding Claim 3:
Jones teaches the method of claim 2, wherein the first end of the capillary is arranged at a distal end of the housing, and the one or more sampling conduits extend from the housing from a proximal end of the housing. As shown in Fig. 2a.
Regarding Claim 7:
Jones teaches the method of claim 1, wherein the one or more sampling conduits comprise one or more inlets, the first end of the capillary and/or the one or more inlets are moveable between a first position in which the one or more inlets are positioned away from the first end of the capillary, and a second position in which the one or more inlets are positioned downstream of the first end of the capillary (see Fig. 2a, in any position the inlet is positioned away from the downstream of the end of the capillary. Further, since the sampling body is moveable between positions, so too are its components.), and wherein the method comprises:
bringing the sample and the first end of the capillary into contact with, or proximate to, each other while the first end of the capillary and/or the one or more inlets are positioned in the first position (13:1-9); and wherein:
causing the charged droplets to be drawn into the one or more sampling conduits comprises moving the first end of the capillary and/or the one or more inlets into the second position such that the charged droplets emitted from the first end of the capillary are drawn into the one or more sampling conduits through the one or more inlets (13:1-16).
Regarding Claim 11:
Jones teaches the method of claim 1, comprising causing evaporation of the charged droplets such that analyte ions are released (16:4-6- the droplets are evaporated at least to the extent that ions are liberated therefrom; 16:24-25 – heating the collection tube would cause evaporation; 17:3 – heating the impactor surface would cause evaporation), and
wherein the analytical instrument analyses the analyte ions (1:12-14; 11:9-14).
Regarding Claim 12:
Jones teaches the method of claim 11, wherein causing evaporation of the charged droplets comprises heating the charged droplets (16:24-25 – heating the collection tube would cause evaporation. 17:3 – heating the impactor surface would cause evaporation).
Regarding Claim 13:
Jones teaches the method of claim 11, comprising using the analysis of the analyte ions to classify the sample, optionally substantially in real time. 17:24-26.
Regarding Claim 14:
Jones teaches the method of claim 11, wherein the analytical instrument is a mass spectrometer and/or an ion mobility spectrometer. 4:5.
Regarding Claim 15:
Jones teaches an apparatus for analysing a sample (Fig. 1), the apparatus comprising:
a capillary comprising a bore that runs centrally along a longitudinal axis of the capillary and forms an outlet at a first end of the capillary (Fig. 2a (10), 7:10-14);
a solvent supply line configured to supply a flow of solvent to the capillary such that solvent passes through the bore of the capillary and is emitted from the outlet of the capillary (Fig. 2a (24), 7:9-14, 15:16-22);
a conductor configured to apply a voltage to solvent supplied to the capillary by the solvent supply line such that charged droplets of the solvent are emitted from the first end of the capillary (7:23-31 describes applying a voltage to the solvent in the capillary, which inherently requires some use of a conductor for transmitting said voltage); and
one or more sampling conduits connectable to an atmospheric interface of an analytical instrument (Fig. 2a (11), 2:12-14; 15:34-16:3),
wherein the one or more sampling conduits comprise one or more inlets (9:20-22, Fig. 4 (52)),
wherein the one or more inlets are moveable relative to the first end of the capillary and/or the first end of the capillary is moveable relative to the one or more inlets (13:1-16), and
wherein the one or more inlets are configured to receive charged droplets emitted from the first end of the capillary when positioned downstream of the first end of the capillary (13:1-16).
Regarding Claim 16:
Jones teaches the apparatus of claim 15, comprising a housing for the capillary, wherein the apparatus is handheld and the housing forms a handle. As shown in Fig. 6B.
Regarding Claim 17:
Jones teaches the apparatus of claim 16, wherein the first end of the capillary is arranged at a distal end of the housing, and the solvent supply line and the one or more sampling conduits extend from the housing from a proximal end of the housing. As shown in Fig. 2a.
Regarding Claim 24:
Jones teaches the apparatus of claim 15, wherein the apparatus is configured such that charged droplets received by the one or more inlets evaporate such that analyte ions are released (16:4-6- the droplets are evaporated at least to the extent that ions are liberated therefrom; 16:24-25 – heating the collection tube would cause evaporation; 17:3 – heating the impactor surface would cause evaporation), and
wherein the analytical instrument is configured to analyse the released analyte ions (1:12-14; 11:9-14).
Claims 1, 5, 6, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0149009 A1 [Levis].
Regarding Claim 1:
Levis teaches a method of analysing a sample (abstract), the method comprising:
providing a capillary having an outlet at a first end (Fig. 1 (102))
supplying a flow of solvent to the capillary such that solvent is emitted from the outlet of the capillary (para 30);
bringing the sample and the first end of the capillary into contact with, or proximate to, each other (see Fig. 2) such that analyte from the sample is absorbed by solvent emitted from the outlet of the capillary (para 30);
applying a voltage to the solvent such that charged droplets of the solvent comprising the analyte from the sample are emitted from the first end of the capillary (paras 26, 30); and
causing the charged droplets to be drawn into one or more sampling conduits (Fig. 12 (104)) connected to an atmospheric (para 28, 39) interface of an analytical instrument (see Figs. 3, 4).
Regarding Claim 5:
Levis teaches the method of claim 1, wherein the charged droplets are emitted from the first end of the capillary as a spray (para 30), and a nebulising gas is not used to form the spray. Para 37.
Regarding Claim 6:
Levis teaches the method of claim 1, wherein the charged droplets of the solvent comprising the analyte from the sample are emitted from the first end of the capillary and are then drawn into the one or more sampling conduits without impacting the sample. As shown in Fig. 2, the droplets pass through the cloud of ablated sample, but do not impact the sample itself.
Regarding Claim 15:
Levis teaches an apparatus for analysing a sample (abstract), the apparatus comprising:
a capillary comprising a bore that runs centrally along a longitudinal axis of the capillary and forms an outlet at a first end of the capillary (Fig. 1 (102));
a solvent supply line configured to supply a flow of solvent to the capillary such that solvent passes through the bore of the capillary and is emitted from the outlet of the capillary (para 30);
a conductor configured to apply a voltage to solvent supplied to the capillary by the solvent supply line such that charged droplets of the solvent are emitted from the first end of the capillary (paras 26, 30) and
one or more sampling conduits connectable to an atmospheric interface of an analytical instrument (Fig. 2 (104)),
wherein the one or more sampling conduits comprise one or more inlets (Fig. 3 (309))),
wherein the one or more inlets are moveable relative to the first end of the capillary and/or the first end of the capillary is moveable relative to the one or more inlets (paras 24, 37), and
wherein the one or more inlets are configured to receive charged droplets emitted from the first end of the capillary when positioned downstream of the first end of the capillary (as shown in Fig. 4).
Regarding Claim 18:
Levis teaches the apparatus of any one of claim 15, configured such that the charged droplets are emitted from the first end of the capillary as a spray by providing the solvent to the capillary and without the use of a nebulising gas. Para 37.
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.
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Jones.
Regarding Claim 4:
Jones teaches the method of claim 1, comprising bringing the sample and the first end of the capillary into contact with, or proximate to, each other without applying the voltage (7:15-22). However, Jones fails to teach the method further comprising the additional steps of then separating the sample and the first end of the capillary, and then applying the voltage.
Jones teaches that the sampling device may be used on multiple samples (17:7-11, 13:25-28)) and in both modes where voltage is applied (7:23-31) and modes where voltage is not applied (7:15-22). As such, it would have been obvious to one of ordinary skill in the art of first sampling a specimen without applying a voltage, then removing the sampler and its components, to include the capillary, and then finally sampling a different specimen with the sampler while applying a voltage. Such an order of rudimentary steps is well within the teaching of Jones, as it simply requires practicing two of the options disclosed therein in sequence. One would have been motivated to make the two measurements above, because this would allow one to analyze two separate specimens under different conditions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Levis in view of US 7,902,499 B2 [Hiraoka]
Regarding Claim 19:
Levis teaches the apparatus of any one of claim 15, comprising a housing for the capillary (Fig. 3 (335)) wherein the first end of the capillary and/or the one or more inlets can move (paras 24 and 37 describe moving the position of the electrospray needle, i.e., the capillary) between a first position in which the one or more inlets are positioned away from the first end of the capillary (as shown in Figs. 1-3, the inlet is always away from the capillary), and a second position in which the one or more inlets are positioned downstream of the first end of the capillary (as shown in Figs. 1-3, the inlet is always downstream of the capillary).
However, Levis fails to teach a moveable member moveably connected to the housing, wherein the capillary and/or the one or more sampling conduits are connected to the moveable member such that.
Hiraoka teaches adjustable stages, i.e., a moveable member, connected to an electrospray needle, i.e., the claimed capillary, allowing the needle to be moved to various positions. 16:9-18. It would have been obvious to one of ordinary skill in the art before the effective time of filing to add the adjustable stages of Hiraoka to the housing of Levis such that the stages moved the electrospray device. One would have been motivated to do so since this would allow for automated adjustment of the electrospray device.
Allowable Subject Matter
Claims 9-10 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WYATT A STOFFA whose telephone number is (571)270-1782. The examiner can normally be reached M-F 0700-1600 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT KIM can be reached at 571 272 2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881