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
Preliminary Amendment
Applicant's amendments, filed October 11, 2024, are respectfully acknowledged and have been fully considered.
Claims 2, 5, 7, 17, 20-22, 30, 32, 33, 36, 37, 46, 50, 58, 60, 62, and 63 are amended. Claims 3, 4, 6, 8-16, 18, 19, 23-29, 31, 34, 35, 38-45, 48, 49, 51-57, 59, 61, and 64-111 are canceled.
Claims 1, 2, 5, 7, 17, 20-22, 30, 32, 33, 36, 37, 46, 47, 50, 58, 60, 62, and 63 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 5 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2, 5, 7, 17, 20-22, 30, 32, 33, 36, 37, 46, 47, 50, 58, 60, 62, and 63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eberlin et al. (U.S. Patent Application 20200279728 A1, hereinafter “Eberlin”).
Regarding Claim 1 (Original), Eberlin teaches an apparatus for producing a sample for analysis (Abstract method and devices are provided for assessing tissue samples from a plurality of tissue sites in a subject using molecular analysis), the apparatus comprising:
a probe comprising a reservoir, a first conduit, a second conduit, and a third conduit (paras 0006,0052 Fig 1E a probe 110 comprising a reservoir 115, a first conduit 111, a second conduit 112 and a third conduit 113); wherein
the reservoir is in fluid communication with the first conduit, the second conduit, and the third conduit (paras 0006,0052 Fig 1E the reservoir 115 is in fluid communication with the first conduit 111, the second conduit 112 and the third conduit 113); and wherein,
when the probe is assembled together with a chamber configured to contain a solvent, a gas supply, and a receptacle (paras 0006,0051,0052 Fig 1D a chamber 120 comprising a solvent; a pressurized gas supply 130; a [receiving] mass spectrometer 140; a probe 110 comprising a reservoir 115, a first conduit 111, a second conduit 112 and a third conduit 113, wherein: the reservoir 115 is in fluid communication with the a first conduit 111, a second conduit 112 and a third conduit 113), then:
the first conduit is configured to be in fluid communication with the chamber, such that the first conduit is configured to deliver a discrete volume of the solvent to the reservoir (par 0006 the first (solvent) conduit 111 is in fluid communication with the chamber 120; par 0010 discrete volume of solvent may flow from the chamber 120 through the first conduit 111 to the reservoir 115);
the second conduit is configured to be in fluid communication with the gas supply, such that the gas supply is configured to deliver a gas to the reservoir (par 0010 a pressurized gas flow from the pressurized gas supply 130 through the second conduit 112 to the reservoir 115); and
the third conduit is in fluid communication with the receptacle, such that the receptacle is configured to receive the sample from the reservoir (par 0010 a sample flow from the reservoir 115 through the third conduit 113 to the mass spectrometer 140).
Regarding Claim 2 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the apparatus further comprises the receptacle, the chamber, the gas supply, or a combination thereof (par 0051 Fig 1D apparatus 100 further comprises the receptacle [receiving] mass spectrometer 140], the chamber 120, and the gas supply 130).
Regarding Claim 5 (Currently Amended), Eberlin teaches the apparatus of claim 1, the apparatus comprising:
the chamber configured to contain the solvent (par 0051 Fig 1D chamber 120 with solvent);
the gas supply (par 0051 Fig 1D pressurized gas supply 130);
the receptacle (par 0051 Fig 1D [receiving] mass spectrometer 140); and
the probe (par 0052 Fig 1E probe 110); wherein:
the first conduit is in fluid communication with the chamber, such that the first conduit is configured to deliver a discrete volume of the solvent to the reservoir (par 0006 the first (solvent) conduit 111 is in fluid communication with the chamber 120; par 0010 discrete volume of solvent may flow from the chamber 120 through the first conduit 111 to the reservoir 115);
the second conduit is in fluid communication with the gas supply and the gas supply is configured to deliver the gas to the reservoir (par 0010 a pressurized gas flow from the pressurized gas supply 130 through the second conduit 112 to the reservoir 115); and
the third conduit is in fluid communication with the receptacle and the receptacle is configured to receive the sample from the reservoir (par 0010 a sample flow from the reservoir 115 through the third conduit 113 to the mass spectrometer 140).
Regarding Claim 7 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the solvent comprises water, an alcohol (par 0009 the solvent may comprise water and/or ethanol), acetonitrile, DMF, or a combination thereof.
Regarding Claim 17 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the gas comprises air, nitrogen (par 0007 the pressurized gas supply provides air to the probe; in other aspects, the pressurized gas supply provides an inert gas such as nitrogen or carbon dioxide to the probe), argon, carbon dioxide, or a combination thereof.
Regarding Claim 20 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the gas supply is configured to provide the gas at atmospheric pressure (par 0013 Fig 1D the supplied gas pressure is less than 10 psig, a range which includes atmospheric pressure [0.0 psig], and thus Eberlin reads on the range of the claim).
Regarding Claim 21 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the gas supply comprises the atmosphere around the apparatus (par 0007 Fig 1D the gas supply 130 provides air, reasonably construed to substantially comprise the atmosphere around the apparatus 100).
Regarding Claim 22 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the gas supply is a pressurized gas supply (par 0007 Fig 1D pressurized gas supply 130).
Regarding Claim 30 (Currently Amended), Eberlin teaches the apparatus of claim 1, further comprising
a pump in fluid communication with the chamber and the first conduit, wherein the pump is configured to transfer the discrete volume of the solvent from the chamber to the reservoir via the first conduit (par 0054 Fig 1D apparatus 100 may comprise a pump 125 configured to transfer the solvent from chamber 120 to the first conduit 111 and reservoir 115).
Regarding Claim 32 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the discrete volume of the solvent is in direct contact with a surface, the surface being a sample site (paras 0012,0058 Fig 1D [the discrete volume of the] solvent is applied to the tissue site 150 (e.g., moved into a reservoir 115 where it is in contact with the sample site 150)).
Regarding Claim 33 (Currently Amended), Eberlin teaches the apparatus of claim 32, wherein
the solvent is delivered to the reservoir such that it contacts the sample site non-destructively (paras 0012,0058 Fig 1D the solvent is applied by a mechanical pump such that solvent is applied to the tissue site (e.g., moved into a reservoir where it is in contact with the tissue site) with minimal force thereby exerting minimal pressure (and producing minimal damage) at a tissue site; par 0013 producing no detectable physical damage to the tissue being assessed).
Regarding Claim 36 (Currently Amended), Eberlin teaches the apparatus of claim 32, wherein
the surface is at least a portion of a tissue from a subject (paras 0012,0058 Fig 1D [the discrete volume of the] solvent is applied to the tissue site 150 (e.g., moved into a reservoir 115 where it is in contact with the sample site 150)).
Regarding Claim 37 (Currently Amended), Eberlin teaches the apparatus of claim 36, wherein
the tissue is in vivo or ex vivo (paras 0014 Fig 1D the plurality of tissue sites comprise 2, 3, 4, 5, 6, 7, 8, 9, 10 or more tissues sites in vivo; or the plurality of tissue sites surround a section of tissue that has been surgically resected (e.g., ex vivo)).
Regarding Claim 46 (Currently Amended), Eberlin teaches the apparatus of claim 1, further comprising
a waste container in fluid communication with the third conduit (par 0061 Fig 1H a waste container 143 and a pump 144 in fluid communication with third conduit 113).
Regarding Claim 47 (Original), Eberlin teaches the apparatus of claim 46, further comprising
a valve configured to diverge a fluid from the third conduit to the waste container (par 0061 Fig 1H valve 142 may be used to diverge a solvent or other cleaning solution from conduit 113 to waste container 143).
Regarding Claim 50 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the probe and/or the apparatus is configured to be hand-held (par 0075 Fig 1A MasSpec Pen was developed as an automated and biocompatible handheld sampling probe).
Regarding Claim 58 (Currently Amended), Eberlin teaches the apparatus of claim 1, further comprising
a control system (par 0055 Fig 1D control system 160) configured to control:
a solvent flow from the chamber through the first conduit to the reservoir (par 0055 Fig 1D configured to control a flow of solvent from chamber 120 through first conduit 111 to reservoir 115);
a gas flow from the gas supply through the second conduit to the reservoir (par 0055 Fig 1D configured to control the pressurized gas flow from pressurized gas container 130 [through the second conduit 112] to reservoir 115);
a sample flow from the reservoir through the third conduit to the receptacle (par 0055 Fig 1D the sample flow from reservoir 115 [through the third conduit 113] to mass spectrometer 140); or
a combination thereof.
Regarding Claim 60 (Currently Amended), Eberlin teaches the apparatus of claim 58, wherein
the control system comprises a haptic control device that controls solvent flow (par 0010 Fig 1A control system comprises a pedal (i.e., that can be operated by foot action) to initiate solvent flow).
Regarding Claim 62 (Currently Amended), Eberlin teaches the apparatus of claim 1, wherein
the apparatus is not directly coupled to an analyzer (par 0065 Fig 1K conduit 113 is not directly connected to mass spectrometer 140 and a venturi device 147 can be used to transport a droplet of sample 150 to ionization device 146 and the interface of mass spectrometer 140).
Regarding Claim 63 (Currently Amended), Eberlin teaches a method for collecting a sample from a surface using the apparatus of claim 1, the method comprising:
(a) contacting the probe with the surface (par 0026 Fig 1E the tip contacts the tissue for analysis);
(b) applying a fixed or discrete volume of the solvent to the surface (par 0013 Fig 1D applying a fixed or discrete volume of a solvent (e.g., using mechanical pump) to a tissue site through a solvent conduit);
(c) collecting the applied solvent to obtain a liquid sample (par 0013 Fig 1D collecting the applied solvent comprises applying a negative pressure to pull the sample into a collection conduit); and
(d) storing the sample in the receptacle (par 0006 Fig 1E the third (collection) conduit 113 is in fluid communication with the [receiving] mass spectrometer 140; the mass spectrometer in communication with a computer that provides a sample analysis of its received sample, i.e. the mass spectrometer is a receptacle; par 0009 collection tip of the probe 110).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK EDWARDS whose telephone number is (571)270-7731. The examiner can normally be reached on Mon-Fri 9a-5p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Eason can be reached on 571-270-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK EDWARDS/Primary Examiner, Art Unit 2624
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