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 .
Response to Arguments
Applicant’s arguments, see page 7 of remarks, filed 9/30/2025, with respect to the claim 24 objection have been fully considered and are persuasive. The objection of claim 24 has been withdrawn.
Applicant's arguments, regarding the 102 rejections, filed 9/30/2025 have been fully considered but they are not persuasive.
Specifically, applicant argues that Shiea et al does not disclose “a receptacle for receiving the adsorbent membrane” because the probes 331 of Shiea et al do not encompass an adsorbent membrane.
However, given the BRI of the term “adsorbent membrane” Sheia et al does disclose an adsorbent membrane as Shiea et al teaches probes 331 made from fused silica fibers or metal fibers and coated with a polymeric adsorption material (wherein the polymeric adsorption material is selected from either polyacrylate (PA) or polydimethylsiloxane (PDMS)(thereby forming an adsorbent membrane), wherein the instant specification discloses that the adsorbent membrane may be constructed of PDMS (see page 2, lines 24-25 of instant specification). Shiea et al also teaches that in this invention, the method for obtaining analytes through a plurality of probes 331 is called "solid phase microextraction (SPME)". The technique achieves the equilibrium of an analyte between adsorption and desorption by coating a polymeric adsorption material onto fused silica fibers or metal fibers (see [0027]).
Furthermore, applicant appears to argue that the membrane of Shiea et al is not semi-permeable (as their membrane may be), however 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. selective permeability) 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).
Similarly, applicant also argues that McEwen et al does not disclose “a receptacle for receiving the adsorbent membrane”.
However, given the BRI of the term “adsorbent membrane”, McEwen et al teaches a receptacle (referred to as enclosure 11) for receiving the adsorbent membrane (wherein the absorbent membrane is interpreted as the tubular region of the probe 47 ) (see [0076]). Furthermore, McEwen et al teaches that the tubular member can also be made of or contain a material such as silica particles or fibers commonly used as liquid chromatography column adsorbents or as solid phase micro extraction (SPME) materials used with gas chromatography (see [0059]). Furthermore, McEwen et al teaches that the solids/liquid introduction probe can be interfaced to a commercially available LC/MS instrument. Compounds can be selectively vaporized from the probe sample introduction device by increasing the temperature of the heated gas that strikes the sample area of the probe. Thus, a separation of compounds is achieved that is based on the volatility of components present in a mixture. Alternatively, a material such as those used for molecular adsorption with liquid or gas chromatography can be use to adsorb compounds with selective release based of adsorption and volatility (see [0085]).
Claim Rejections - 35 USC § 102
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) 18-20, 26 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shiea et al (US PGPub 2015/0144777), as cited on the IDS.
Regarding Claim 18, Shiea et al teaches a system for analyzing volatile organic compounds (VOCs) adsorbed on an adsorbent membrane, by low-temperature plasma and mass spectrometry (LTP-MS) (as illustrated in Figure 1 and see [0023]-[0024]), comprising: a receptacle (referred to as sampling unit 33) for receiving the adsorbent membrane (where the adsorbent membrane is comprised of a plurality of probes 331, where the probes 331 are made from fused silica fibers or metal fibers and coated with a polymeric adsorption material ) (see [0026]-[0027]) ; a low-temperature plasma ionizer (referred to as charge producing unit 31) suitable for emitting a plasma stream in a plasma emission direction, thus ionizing the VOCs adsorbed by the membrane and forming an ionized gas laden with VOCs (see [0024], [0031] and [0040]); and a mass spectrometer (2) to analyze the ionized VOCs (see [0023] and [0031]).
Regarding Claim 19, Shiea et al teaches that the system (of claim 18) further comprises a heater (32) for heating the adsorbent membrane (see Figure 1 and [0025]).
Regarding Claim 20, Shiea et al teaches that the receptacle (sampling unit 33) is positioned outside the plasma stream (as illustrated in annotated Figure 1) and wherein: the receptacle is a container that is resealable so as to form a sealed environment (through the use fixing portion 333) except for an inlet (i.e. sample inlet 324) and an outlet (i.e. outlet 325)(see Figure 1 and [0026]) ; the container comprises a carrier gas inlet (i.e. inlet 322. Including inlet 324) for the entry of a carrier gas into the container and a gas outlet (i.e. outlet 325) for the exit of a gas potentially laden with VOCs (see Figure 1, [0025]-[0026], [0030] and [0032]).
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Regarding Claim 26, Shiea et al teaches that the receptacle (i.e. sampling unit 33) is arranged under the plasma stream such that the plasma stream (shown in annotated Figure 1 above) is directed towards the membrane (i.e. probe 331) when the membrane is received in the receptacle (see [0029]-[0031] and [0040]).
Regarding Claim 29, Shiea et al teaches a method for analyzing VOCs adsorbed on an adsorbent membrane, by LTP-MS, using the system according to claim 18 (see [0015] and [0028]-[0031]), the method comprising: providing an adsorbent membrane (referred to as probes 331, as described above) on which VOCs have been adsorbed (see [0026], [0029]-[0030]); desorbing the VOCs adsorbed on the adsorbent membrane (see [0028], [0030] and [0040]) ; low-temperature plasma ionizing (through charge producing unit 31) the desorbed VOCs, thereby forming an ionized gas (see [0024]-[0025] and [0031]); and analyzing the ionized gas, by mass spectrometry (using mass 11spectrometer 2) (see [0023]-[0025], [0028] and [0031]).
Claim(s) 18-22, 26, 28 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McEwen et al (US PGPub 2011/0031392).
Regarding Claim 18, McEwen et al teaches a system for analyzing volatile organic compounds (VOCs) adsorbed on an adsorbent membrane, by low-temperature plasma and mass spectrometry (LTP-MS) (as illustrated in Figure 1 and described in [0075]), comprising: a receptacle (referred to as enclosure 11) for receiving the adsorbent membrane (wherein the absorbent membrane is interpreted as the tubular region of the probe 47 ) (see [0076]) ; a low-temperature plasma ionizer (referred to as ionization region 19) suitable for emitting a plasma stream in a plasma emission direction, thus ionizing the VOCs adsorbed by the membrane and forming an ionized gas laden with VOCs (see [0076], [0078], [0081] and [0086]); and a mass spectrometer (50) to analyze the ionized VOCs (see [0052] and [0075]).
Regarding Claim 19, McEwen et al teaches that the system (of claim 18) further comprises a heater (referred to as heating device 26, such as a resistive heater) for heating the adsorbent membrane (see Figure 1 and [0076]).
Regarding Claim 20, McEwen et al teaches that the receptacle (i.e. enclosure 11) is positioned outside the plasma stream (produced in ionization region 19) (see Figure 1) and wherein: the receptacle is a container that is resealable so as to form a sealed environment except for an inlet (i.e. port 23) and an outlet (23) ([0076] and [0078]); the container (enclosure 11) comprises a carrier gas inlet (referred to as gas introduction 24) for the entry of a carrier gas into the container and a gas outlet (15) for the exit of a gas potentially laden with VOCs (see [0078] and [0086]).
Regarding Claim 21, McEwen et al teaches a carrier gas injection tube (referred to as inlet 27) extending along a gas injection axis and of which one end, the outlet (i.e. bottom) end, opens into the closed container (see [0081] and Figure 1) , the closed container (enclosure 11) being configured to hold the adsorbent membrane (probe 47) so that its surface is perpendicular to the gas injection axis (see Figure 1), thereby enabling the carrier gas to become laden with VOCs as it passes through the membrane; and a guide tube (referred to as sheath tube 26A) for conveying the VOC-laden carrier gas to the ionizer (see [0086]).
Regarding Claim 22, McEwen et al teaches that the closed container (enclosure 11) comprises a membrane support (referred to as flange 30) for supporting a membrane (i.e. probe 47), a sampling inlet (i.e. port 23) for the entry of a sample gas and the loading of the membrane with VOCs, a sampling outlet (15) for the exit of the sample gas, a carrier gas inlet (see [0075]-[0079]).
Regarding Claim 26, McEwen et al teaches that the receptacle (i.e. the bottom portion of enclosure 11) is arranged under the plasma stream (from ionization region 19) such that the plasma stream is directed towards the membrane when the membrane is received in the receptacle (see Figure 1 and [0076]).
Regarding Claim 28, McEwen et al teaches that the ionizer (ionization region 19) is an ionizer with at least one electrode (i.e. electrode 16 and counter electrode 18) (see [0054], [0075], [0081] and [0086]).
Regarding Claim 29, McEwen et al teaches a method for analyzing VOCs adsorbed on an adsorbent membrane, by LTP-MS (see [0051] and [0068]) , using the system according to claim 18 (see Figure 1 and [0075]-[0076]), the method comprising: providing an adsorbent membrane (referred to as probe 47, described above) on which VOCs have been adsorbed (see [0059] and [0085]); desorbing the VOCs adsorbed on the adsorbent membrane (see [0085]) ; low-temperature plasma ionizing (through ionization region 19) the desorbed VOCs, thereby forming an ionized gas (see [0075]-[0078] ); and analyzing the ionized gas, by mass spectrometry (using mass spectrometer 2) (see [0052]-[0056], [0075] and [0085]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21- 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shiea et al as applied to claim 20 above, and further in view of McEwen et al (US PGPub 2011/0031392).
Regarding Claim 21, Shiea et al teaches a carrier gas injection tube (i.e. air flow path 323) extending along a gas injection axis and of which one end, the outlet (bottom) end, opens into the closed container (see [0025], [0040] and Figure 1), the closed container (sampling unit 33) being configured to hold the adsorbent membrane (probe 331) so that its surface is perpendicular to the gas injection axis, thereby enabling the carrier gas (which may be nitrogen gas) to become laden with VOCs as it passes through the membrane (see [0040]).
Shiea et al does not disclose a guide tube for conveying the VOC-laden carrier gas to the ionizer.
However, in the analogous art of ionization and analysis of volatile compounds, McEwen et al teaches a guide tube (referred to as sheath tube 26a) which conveys the VOC-laden carrier gas to the ionizer (the ionization region 19) (see [0076] and [0086]). It would have been obvious to one of ordinary skill in the art to modify the system of Shiea et al by further incorporating a guide tube to convey VOC-laden carrier gas to the ionizer (as taught by McEwen et al and described above) for the benefit of ensuring that heated solution is securely transported to the ionization region 19, such that it can be analyzed.
Regarding Claim 22, the combination of Shiea et al and McEwen et al teaches claim 21 (as described above).
Furthermore, McEwen et al teaches that the closed container (enclosure 11) comprises a membrane support (referred to as flange 30) for supporting a membrane (i.e. probe 47), a sampling inlet (i.e. port 23) for the entry of a sample gas and the loading of the membrane with VOCs, a sampling outlet (15) for the exit of the sample gas, a carrier gas inlet (see [0075]-[0079]).
Claims 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McEwen et al as applied to claim 20 above, and further in view of Amirav et al (US PGPub 2010/0019140).
Regarding Claim 24, McEwen et al does not teach a guide tube and wherein: the container outlet is extended by the guide tube, the free end of the tube being close to the plasma stream when said stream is emitted so that the plasma ionizes the laden gas at the tube outlet.
However, in the analogous art of sample introduction into mass spectrometers, Amirav et al teaches a system for introducing a sample into a mass spectrometer, which includes a gas supply line 7 and a GC-MS transfer line 3 (see [0019] and Figure 1). Furthermore, Amirav et al teaches that the system further includes a guide tube ( i.e. glass tube or rod 18) at the end of the container (i.e. open probe oven 1)(see [0022 and Figure 1). It would have been obvious to one of ordinary skill in the art to modify the container of McEwen et al by further incorporating a guide tube (as taught by Amirav et al) which extends out of the container outlet for the benefit of securely transporting sample through the guide tube into the mass spectrometer for further analysis.
Regarding Claim 27, McEwen et al teaches that the receptacle is a container that is resealable (i.e. enclosure 11) so as to form a sealed environment except for inlets and an outlet (15); the container further comprising a carrier gas inlet (i.e. port 23) for the entry of a carrier gas into the container, a gas outlet (15) for the exit of the ionized gas, and a plasma inlet (such as inlet 27).
McEwen et al does not disclose that the outlet is extended by a guide tube for guiding the ionized gas towards the inlet of the mass spectrometer.
However, in the analogous art of sample introduction into mass spectrometers, Amirav et al teaches a system for introducing a sample into a mass spectrometer, which includes a gas supply line 7 and a GC-MS transfer line 3 (see [0019] and Figure 1). Furthermore, Amirav et al teaches that the system further includes a guide tube ( i.e. glass tube or rod 18) at the end of the container (i.e. open probe oven 1)(see [0022 and Figure 1). It would have been obvious to one of ordinary skill in the art to modify the container of McEwen et al by further incorporating a guide tube (as taught by Amirav et al) which extends out of the container outlet for the benefit of securely transporting sample through the guide tube into the mass spectrometer for further analysis.
Claims 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over McEwen et al (or Shiea et al) as applied to claims 29-30 above, and further in view of Karancsi et al (US PGPub 2018/0038838).
Regarding Claims 30-34, neither McEwen et al nor Shiea et al teaches that the analyzing the ionized gas by mass spectrometry involves comparing obtained spectra (obtained from analyzing the membrane for VOCs) with a database of molecular fingerprints to determine a patient’s medical status (i.e. one of at least the stage, grade or type of breast cancer).
However, in the analogous art of performing ambient ionization mass and/or ion mobility spectrometry, Karancsi et al teaches analyzing an aerosol, surgical smoke or vapor generated from a target. The device may comprise an ion analyzer or mass spectrometer 207 having an inlet 206, a vacuum region 208, a solid collision surface 209 and ion optics 212 such as a Stepwave (RTM) ion guide arranged within the vacuum region 208. The device also may include a sample transfer tube 202 and a matrix introduction conduit 203. The sample transfer tube 202 has an inlet for receiving the aerosol sample 201 (which may correspond to the surgical smoke, vapor or aerosol described in relation to FIG. 1) from a sample being investigated and an outlet that is connected to the inlet 206 of the ion analyzer 207. The matrix introduction conduit 203 has an inlet for receiving a matrix compound and an outlet that intersects with the sample transfer tube 202 so as to allow the matrix 204 to be intermixed with the aerosol sample 201 in the sample transfer tube 202 (see [0532]). Furthermore, Karancsi et al teaches that thousands of database entries are able to be recorded and compared with the analysis results (from the ion analyzer) in order to determine or diagnosis various types or grades of breast cancer (see [0236], [0415], [0511] and [0513]). Accordingly, it would have been obvious to one of ordinary skill in the art to utilize the system or method of McEwen et al (or Shiea et al) with the sample compounds of Karancsi et al for the benefit of enabling a user to easily determine and compare the analysis results (from analysis of samples ionized on the adsorbent) in order to determine or diagnosis various types or grades of breast cancer and to distinguish between potentially cancerous and non-cancerous tissue; (iii) to distinguish between different types or grades of cancerous tissue; (iv) to distinguish between different types or classes of target material; (v) to determine whether or not one or more desired or undesired substances are present in said target; (vi) to confirm the identity or authenticity of said target; (vii) to determine whether or not one or more impurities, illegal substances or undesired substances are present in said target; (viii) to determine whether a human or animal patient is at an increased risk of suffering an adverse outcome; (ix) to make or assist in the making a diagnosis or prognosis; and (x) to inform a surgeon, nurse, medic or robot of a medical, surgical or diagnostic outcome (see [0236] of Karancsi et al).
Allowable Subject Matter
Claims 23 and 25 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.
Regarding Claim 23, the prior art neither teaches nor fairly suggests that the membrane support is a membrane magazine configured to be moved in rotation and/or translation and comprising a plurality of membrane housing compartments, the membrane magazine being mounted so as to place a single housing compartment, the housing compartment under analysis, opposite the outlet end of the injection tube and the inlet end of the guide tube.
Regarding Claim 25, the prior art neither teaches nor fairly suggests a connector with at least two arms, and wherein: a first arm is connected to the outlet of the container; a second arm has one end directed towards the inlet of the mass spectrometer; the ionizer is configured so that the plasma stream is directed towards an opening between the first and second arm or a third arm during operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Chung et al (US PGPub 2014/0235829) discloses parallel or serial ionization of a gas mixture by activating at least two ionization devices operating using different ionization procedures, and/or by ionizing the gas mixture in a detector to which the gas mixture and ions and/or metastable particles of an ionization gas are fed. The method also includes detecting the ionized gas mixture in the detector for the mass spectrometric examination thereof (see abstract).
THIS ACTION IS MADE FINAL. 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 JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797