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 Amendment
The Amendment filed 12/19/2025 has been entered. Claims 1-15 remain pending in the application. Claims 1,3, 10, 12, and 14 have been amended.
Status of Objections and Rejections
The objection to the drawings and specification have been withdrawn in view of Applicant's amendment.
The objection to claim 1 is maintained. The objection to claims 2-9 is maintained based upon dependency of all the limitations of claim 1.
New grounds of claim objection are necessitated by the amendments.
New grounds of rejection under 35 U.S.C. 112(b) are necessitated by the amendments.
All rejections from the previous office action under 35 U.S.C. 103 are maintained.
Response to Arguments
Applicant's arguments, see pages 7-12, filed 12/19/2025, with respect to the rejection of claims 1-15, under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant argues (p. 8) that the amended claims specify that the first sorbent must be “coated on an inner surface of a closed bottom portion of the vial”. Applicant relies on Fig. 1 of prior art, Tipler, to show that the sorbents 140 and 150 are disposed on the side walls of the vial and not the bottom surface.
The Examiner respectfully disagrees.
Page 5 of the previous office action references Fig. 10 of Tipler which clearly depicts first sorbent 1040 disposed at the closed bottom portion of the vial, sampling outlet 1020, which is “closed or sealed” ([0055][0036]). Therefore, regarding claims 1 and 10, the teachings of Tipler still satisfy the amended claim limitation, “a sampling device that includes a vial with a first sorbent coated on an inner surface of a closed bottom portion of the vial”, and the rejection is maintained.
Applicant argues (p. 9) that the Examiner relies upon Cardin to teach a sampling device that is compatible with solvent extraction, however Cardon does not collect an air sample using a diffusive sampling process as claimed. Applicant further remarks that incorporating Cardin’s use of liquid or solid samples into the apparatus of Tipler would frustrate the intend use of Tipler for diffusive sampling.
The Examiner respectfully disagrees.
Primary reference, Tipler, is relied upon for teaching the collection of an air sample using a diffusive sampling process ([0033], [0002]) while Cardin is used to confirm that a particular sorbent is capable of solvent extraction ([0039]). Solvent extraction only requires that a solvent contacts a sorbent and dissolves an analyte. Both Tipler and Cardin use the same solvent material of Tenax (Tipler, [0062]; Cardin, [0027]), and Tipler even states that the sorbent is bonded to the inner surface body using the same technique for manufacturing solid phase micro extraction columns ([0048]). One of ordinary skill in the art would reasonably expect that the sampling device taught by Tipler would also be compatible with sample extraction since sorbent material Tenax is well-known in the art to be compatible with many organic solvents. The instant claims do not recite that a liquid or solid sample is collected, only that the device is compatible with solvent extraction while giving the option of using either thermal desorption or solvent extraction (Emphasis added). Nonetheless, Tipler teaches “that fluid is permitted to diffuse into the device through the sampling inlet” to desorb analytes ([0036]), further confirming the sampling device of Tipler to be solvent-compatible. The rejection of claims 1-15 is therefore, maintained.
Drawings
The drawings were received on 12/19/2025. These drawings are acceptable.
Specification
The amended specification was received on 12/19/2025 and has been entered.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Regarding claim 1, the claim does not present the elements in a logical sequence thereby impairing readability. The Examiner suggests rephrasing the collecting step and specific device used with it. Applicant may correct ll. 2-4, 11-13 of the claim to read:
“collecting an air sample in a diffusive sampling process, using a sampling device that includes a vial with a first sorbent coated on an inner surface of a closed bottom portion of the vial, the first sorbent including an adhesive surface,
“coupling
the sampling device to a preconcentration device including a third sorbent disposed in a cavity by removing the inert cap and coupling via an opening of the sampling device”.
Claims 2-9 are rejected based upon dependency of all the limitations of claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, ll. 8 and 12 recite “a preconcentration device”. It is unclear as to whether the second mention of “a preconcentration device” in line 12 is in reference to the same preconcentration device in line 8 or a different preconcentration device. Applicant may amend the claim by reciting “the preconcentration device” in line 12.
Claims 2-9 are rejected based upon dependency of all of the limitations of claim 1.
Regarding claim 6, l. 3 recites “a vacuum source”. It is unclear as to whether this vacuum source is in reference to the same vacuum source of independent claim 1 or a different vacuum source. Applicant may amend the claim by reciting “the vacuum source” in line 1. 3 of claim 6.
Claim Interpretation
The claims contain limitations which are directed to intended uses or capabilities of the claimed invention. These limitations are only given patentable weight to the extent which effects the structure of the claimed invention. Please see MPEP 2114. Note that functional limitations are emphasized in italics herein.
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 1-6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tipler et al. (US 20100242579 A1) in view of Spero (US 20220395834 A1, filing date 2020-11-16), Mengel et al. (US 6244117 B1), and Cardin (WO 2018013946 A1).
Regarding claim 1, Tipler teaches a method (a method; [0033]) comprising:
collecting (The VOCs may be collected; [0033]), using a sampling device (the sorbent device 1000; [0055]; Fig. 10) that includes a vial (body 1005; [0055]; Fig. 10) with a first sorbent (item 1040 in Fig. 10; See [0055]) coated (techniques such as gas deposition, vapor deposition or the like can also be used to deposit the materials in the sorbent devices; [0048]) on an inner surface of a closed bottom portion of the vial (inner surface of the body of the sorbent device; [0048])(Fig. 10 shows sorbent 1040 disposed at the bottom portion of the vial, sampling outlet 1020, which is “closed or sealed” ([0055][0036]), an air sample (drawing a sample of gas (typically ambient air; [0033]) in a diffusive sampling process ( “internal, longitudinal diffusion path to permit passive sampling of samples that include a plurality of species having varying boiling points”; [0033];[0002]),
wherein the first sorbent is bonded to the inner surface of the vial (the sorbent materials can be chemically bonded to the inner surface of the body of the sorbent device; [0048]),
sealing the sampling device using a cap (After the species are adsorbed, the sampling inlet 110 can be capped or covered; [0038]);
using thermal desorption or solvent extraction, via a preconcentration device (thermal desorption instrument; [0033]), to deliver one or more compounds of the air sample to a gas chromatograph for chemical analysis (“the sorbent device having the adsorbed analytes is subsequently heated in a thermal desorption instrument, and a flow of inert gas, such as helium, nitrogen or hydrogen, is provided to sweep the VOCs out of the sorbent device and into a chromatographic column for separation and analysis,” as a part of a “gas chromatography system”; [0033];[0067]),
coupling, via an opening of the sampling device, the sampling device to a preconcentration device (“coupling the sorbent device to a thermal desorption analyzer,” wherein the thermal desorption analyzer is coupled to the open base of the sampling device; Tipler, [0011],[0036]; See base 1020 of Fig. 10)(The Examiner interprets this preconcentration device to be the same one used in the thermal desorption step. See 112(b) above), and
recovering the one or more compounds by heating the one or more compounds with a heat source (“heating the sorbent device…to release volatiles from the sorbent material…to desorb the collected components in a narrow band into the GC column for separation,” wherein the heat source is within the “thermal desorption instrument”; Tipler, [0067][0033]).
Tipler is silent to teaching the first sorbent includes an adhesive surface, the sampling device is compatible with solvent extraction, that an inert cap is removed before coupling the sampling device to a preconcentration device that includes a third sorbent disposed in a cavity (Emphasis added), and using a vacuum source for compound recovery.
Spero teaches the first sorbent includes an adhesive surface (“micro posts 122 are pre-functionalized with avidin end groups,” wherein “adhesion between silica and PDMS can be used to attach silica capture beads to PDMS micro posts”; [00164][0087]; See Fig. 12).
Spero is considered to be analogous to the claimed invention because it is in the same field of endeavor for sorbent-based collection of analytes in air samples (Spero, [0062]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first sorbent layer (1040 in Fig. 13 of Tipler) taught by Tipler to incorporate the adhesive surface taught by of Spero in order to stabilize the stacked sorbent layers. Tipler already relies on stacked sorbent beds arranged by strength for capturing species of varying boiling points while the beds are packed together during use ([0038][0054]). The material of the different sorbent layers can be PDMS and fused silica beads (Tipler, [0062][0063]). Likewise, Spero teaches two layers of sorbent material but also teaches an adhesive surface on the PDMS layer in order to bind with the next layer of silica beads ([00165][00850; Fig. 12). PDMS-based adhesion is a known technique in the art that would predictably stabilize the first layer, reduce bead migration, and maintain a consistent diffusion path (Tipler, “825 between the walls of the body 805 of the sorbent device 800 and the packed sorbent materials 830-840”; [0054]; Fig. 8) resulting in an improved system (See MPEP 2143(I)(A)).
Tipler is silent to teaching the sampling device is compatible with solvent extraction, that an inert cap is removed before coupling the sampling device to a preconcentration device that includes a third sorbent disposed in a cavity (Emphasis added), and using a vacuum source for compound recovery.
Cardin teaches a sampling device that is compatible with solvent extraction (sample extraction device…can be used to extract samples…using a solvent; [0039]).
Cardin is considered to be analogous to the claimed invention because it is in the same field of endeavor of sorbent-based collection of volatile/semivolatile chemicals for chromatographic analysis ([0047][0054]). Solvent extraction only requires that a solvent contacts a sorbent and dissolves an analyte. Both Tipler and Cardin use the same solvent material of Tenax (Tipler, [0062]; Cardin, [0027]), and Tipler even states that the sorbent is bonded to the inner surface body using the same technique for manufacturing solid phase micro extraction columns ([0048]). Additionally, Tipler teaches “that fluid is permitted to diffuse into the device through the sampling inlet” to desorb analytes ([0036]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specified the sorbent device taught by Tipler in view of Spero to be compatible with solvent extraction as taught by Cardin. Doing so would enable the device to “extract samples that are better recovered using a solvent, rather than via thermal desorption prior to GC or GCMS” and even “LC and/or LCMS” (Cardin, [0039]). Implementing the known alternative of solvent addition when using the device taught by Tipler is a combination of elements according to known methods to yield predictable results, since either method (thermal desorption or solvent extraction) would merely function as it does separately (See MPEP 2143(I)(A)).
Tipler is silent to teaching that an inert cap is removed before coupling the sampling device to a preconcentration device that includes a third sorbent disposed in a cavity (Emphasis added), and using a vacuum source for compound recovery.
Tipler teaches that a cap is placed on the inlet of the device for containing the sample after collection ([0038]). However, the thermal desorption analyzer (preconcentration device) is not attached to the sampling inlet. It is attached to the sample outlet which is closed/sealed and then opened for desorption ([0036]; See inlet 1010 and outlet 1020 of Fig. 20). Tipler does not mention a structure by which the sampling outlet is closed/sealed such that air does not diffuse into the sorbent device 100 through the base. There are only a finite number of identified solutions for sealing the sampling outlet, and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sampling device taught by Tipler in view of Spero and Cardin by adding another cap to the sampling outlet. Doing so represents a predictable solution with a reasonable expectation of success since the same type of cap is used to cover the inlet of the device and is capable of preventing release of the sample until analysis (See MPEP 2143(I)(E)).
Tipler fails to teach an inert cap, the preconcentration device includes a third sorbent disposed in a cavity (Emphasis added), and using a vacuum source for compound recovery.
Mengel teaches an inert cap (caps are made of inert material; column 5, line 28-30; Fig. 3)
Mengel is considered to be analogous to the claimed invention because it is in the same field of endeavor for collecting volatile samples (Trapping Contaminants Contained In A Gas; Title). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic cap taught by Tipler in view of Spero and Cardin by with the inert cap taught by Mengel so “that there is essentially no chance of interaction between sample constituents and the cap material” (Mengel, column 5, line 28-30; Fig. 3). One of ordinary skill in the art would have recognized that applying this known technique would have yielded predictable results and resulted in an improved system (See MPEP 2143(I)(B)).
Tipler fails to teach that preconcentration device includes a third sorbent disposed in a cavity (Emphasis added), and using a vacuum source for compound recovery.
Cardin teaches a preconcentration device (The sample extraction device; [0042) that includes a third sorbent disposed in a cavity ((lower cavity 220)— which can include a sorbent (e.g. , sorbent 202)— of the sample extraction device; [0042; Fig. 2B), and using a vacuum source for compound recovery (“a vacuum source can be coupled to the sample extraction device 100 at the valve end 214,” while “creating a vacuum to increase recovery of low volatility compound”;[0028], Abstract).
Cardin is considered to be analogous to the claimed invention because it is in the same field of endeavor for diffusive gas sampling. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sampling device taught by Tipler in view of Spero, Cardin, and Mengel by further incorporating the teachings of Cardin and including a third sorbent disposed in the secondary trap of Tipler, diffusively transferring the one or more compounds of the air sample to this third sorbent, and using a vacuum for compound recovery during heating. One of ordinary skill in the art would have recognized that placing a simple barrier filter within the thermal-desorption analyzer at the trap outlet, upstream the GC inlet is merely a combination of elements according to known methods to yield predictable results. For example, Cardin teaches that a benefit of the sorbent device is filtering unknown compounds that may interfere with analysis before the sample enters the GC (Cardin, [0035]), leaving only volatile and semivolatile compounds as the analytes of interest ([0033]). Tipler already teaches a diffusive sorbent device intended for the analysis of volatile compounds using a thermal desorption analyzer and explains the configuration of the path of the diffused sample en route to the GC ([0067]); Cardin depicts where the pre-column enrichment sorbent would routinely sit in such a configuration (Fig. 2B). Therefore, by adding a small filter element in Tipler’s thermal desorption path to the GC and using vacuum pressure while heating the sample (already taught by Tipler) ([0067]), each element of the system would merely perform the same function as they would separately and achieve Cardin’s stated protections and facilitated sample transfer (See MPEP 2143(I)(A)).
Regarding claim 2, The method of claim 1, wherein the sampling device further includes a second sorbent (item 1038 in Fig. 10 of Tipler) bonded to the adhesive surface of the first sorbent (adhesion between silica and PDMS can be used to attach silica capture beads to PDMS micro posts,” by “using a chemical bond”; Spero, [0087]; Fig. 12).
Regarding claim 3, Modified Tipler teaches the method of claim 1, further comprising,
applying heat to the first sorbent (“heating the sorbent device,” wherein the first sorbent is bonded to the sorbent device and is also heated; Tipler, [0067]); and
while applying the heat to the first sorbent, diffusively transferring the one or more compounds of the air sample from the first sorbent (During this heating, a carrier gas such as helium, nitrogen or hydrogen flows through the tube at a desired flow rate to transfer the contents of the sorbent tube onto a…secondary trap; Tipler, [0067]).
Modified Tipler is silent to teaching a heater configured to apply more heat to the first sorbent than to the third sorbent.
Modified Tipler instead teaches one or more compounds are transferred to a cooled secondary trap (cavity), when the sampling device is heated ([0067]).
Cardin teaches a heater (using a heater; [0048]).
Cardin is considered to be analogous to the claimed invention because it is in the same field of endeavor for sorbent-based collection of volatile/semivolatile chemicals for chromatographic analysis ([0047][0054]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diffusive sampling system taught by Tipler in view of Spero, Mengel and Cardin to further incorporate the teachings of Cardin by including a a heater as means for heating the first and third sorbents. There are only a finite number of identified solutions for heating the sorbent device as taught by Tipler ([0033]) and doing so represents a predictable solution with a reasonable expectation of success (See MPEP 2143(I)(A and E)).
Modified Tipler fails to teach that more heat is applied to the first sorbent than to the third sorbent.
However, paragraphs [0034] and [0048] of Cardin teach varying the temperature, vacuum, and cycling conditions between the vial and the sample extraction device, and the “sample extraction device heating can be omitted,” while “heating the sample can cause an aqueous solution to boil (The sample extraction device containing the third sorbent, and the sample being attached to the first sorbent; See [0048]). These parameters are result-effective variables used to achieve maximum sample extraction based on the volatility of the compounds of interest which may be achieved by applying more heat to the first sorbent than to the third sorbent (See MPEP 2144.05(II)). One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to adjust relative temperatures between sorbent regions or optimize heating intensity by applying more heat to the first sorbent than to the third sorbent to achieve predictable improvements in analyte transfer (See MPEP 2143(I)(D)).
Regarding claim 4, Modified Tipler teaches the method of claim 3, wherein using thermal desorption to deliver the one or more compounds of the air sample (various compounds of the sample can move; Cardin, [0022]) to the gas chromatograph for chemical analysis includes thermally desorbing the third sorbent (“the chemical analysis device 160 can desorb sample from the sample extraction device 100 using a thermal desorber,” wherein the “chemical analysis device 160…can correspond to a chromatograph configured to perform gas chromatography (GC),” and wherein the “sorbent [is] inside sample extraction device 100”; Cardin, [0019][0018][0021]]; Fig. 1A).
Regarding claim 5, Modified Tipler teaches the method of claim 3, further comprising sealing the sampling device and preconcentration device to form a closed system using a valve of the preconcentration device (“sealing plunger 204 can be depressed to open the top of the valve,” and “after the sample has been collected by the sample extraction device 200, the sealing plunger 204 can be remain closed…and can isolate the sample from the environment, allowing the sample to be stored in the sample extraction device 200; Cardin; [0029]; Fig. 2B).
Regarding claim 6, Modified Tipler teaches the method of claim 3, further comprising drawing a vacuum in the preconcentration device and the sampling device while the preconcentration device and sampling device are coupled (while the sample extraction device 200 is inserted into sample vial 250, a vacuum can be pulled in sample vial 250 through the sample extraction device 200; Cardin, [0032]) using a vacuum source coupled to a valve of the preconcentration device (a vacuum source can be coupled to the sample extraction device 100 at the valve end 214; Cardin, [0028]).
Regarding claim 8, Modified Tipler teaches the method of claim 3, wherein the heat is applied to the first sorbent while the sampling device and preconcentration device form a closed system under vacuum (“the sample vial can remain under vacuum and applied heat for a predetermined amount of time,” which thereby produces a closed system and wherein the sample extraction device is already attached to the sample vial according to step 304 of Fig. 3; Cardin, [0044].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tipler et al. (US 20100242579 A1) in view of Spero (US 20220395834 A1, filing date 2020-11-16), Mengel et al. (US 6244117 B1, 2001), and Cardin (WO 2018013946 A1; see attached English translation), as applied to claim 3 above, and in further view of Bouvier (US 20170282096 A1).
Regarding claim 7, Modified Tipler teaches the method of claim 3,
Modifed Tipler fails to teach coupling the sampling device and the preconcentration device using a vacuum sleeve around the preconcentration device.
Bouvier teaches using a vacuum sleeve around a separation device (vacuum insulated jacket surrounds the chromatography column; [0005]).
Bouvier is considered to be analogous to the claimed invention because it is in the same field of endeavor for desorption of volatile and semi-volatile analytes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample extraction device taught by Tipler in view of Spero, Mengel, and Cardin to incorporate the teachings of Bouvier by including a vacuum jacket around the sample extraction device. It is known in the field of separation chromatography that the use of a vacuum jacket yields an insulating effect while the extraction process proceeds within the separation device. Cardin identifies condensation and analyte loss as a problem when attempting to maintain the sampling path at a controlled temperature to preserve volatile components ([0048]). Bouvier teaches surrounding a device with a vacuum jacket to thermally insulate the internal flow path, thereby reducing heat loss and preventing condensation during the transfer of analytes ([0072]). One of ordinary skill in the art would have found it obvious to use the vacuum-jacketed insulation taught by Bouvier around Cardin’s sample extraction device by applying a known technique to a similar device to yield predictable results (See MPEP 2143(I)(A)).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tipler et al. (US 20100242579 A1) in view of Spero (US 20220395834 A1, filing date 2020-11-16), Mengel et al. (US 6244117 B1, 2001), and Cardin (WO 2018013946 A1; see attached English translation), as applied to claim 1 above, and in further view of O’Ham (US 20120184795 A1).
Regarding claim 9, Modified Tipler teaches the method of claim 1,
Modified Tipler fails to teach, prior to collecting the air sample in the diffusive sampling process: coupling the sampling device to a manifold; and while the sampling device is coupled to the manifold: drawing a vacuum in the sampling device through the manifold while applying heat to the first sorbent.
O’Ham teaches prior to collecting the air sample (O’Ham explains that the Matrix Constituent Separator, or manifold provides a cleaning process for reusing matrices such as sorbents; therefore the following steps would have occurred prior to the collection; [0030][0020]) in the diffusive sampling process: coupling the sampling device (“establishing a vacuum…through the top of the container,” and “charging the matrices into bottom screened trays which are mechanically placed into a heating frame,” wherein the matrices are sorbents within the container; [0035];[0020]; Fig. 1) to a manifold (“manifold for removal of gases,” or “The Matrix Constituent Separator”; [0016][0028];Fig. 1) and
while the sampling device is coupled to the manifold: drawing a vacuum in the sampling device through the manifold (while applying heat to the first sorbent (“establishing a vacuum…through the top of the container to establish an up draft through the…packed matrices, heating the matrices from the bottom and pulling the hot gases upwardly behind or commingled with the gases, releasing the contaminants vapors from the matrices and removing them from the trays and manifold frame and collecting the contaminants vapors in an air emission control system if desired; [0035]).
O’Ham is considered to be analogous to the claimed invention because it is in the same field of endeavor for desorption of volatile and semi-volatile organic and volatile inorganic chemicals ([0028]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Tipler in view of Spero, Mengel, and Cardin to incorporate the teachings of O’Ham by including a pre-cleaning step in order to reuse the sampling container with the sorbent for another sample. O’Ham explains that “The Matrix Constituent Separator provides efficient, cost-effective separation for recovery of hazardous and non-hazardous organic and inorganic chemical constituents and matrices for recycling, reuse, economic disposal or further treatment of the hazardous constituents. It would have been advantageous to reap these same benefits for the method taught by modified Tipler by using the MCS taught by O’Ham.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tipler et al. (US 20100242579 A1) in view of Spero (US 20220395834 A1, filing date 2020-11-16), Mengel et al. (US 6244117 B1), Cardin (WO 2018013946 A1), and Psyllaki (US 20210156768 A1, filing date 2020-11-20).
Regarding claim 10, Tipler teaches a system comprising:
a sampling device (the sorbent device 1000; [0055]; Fig. 10) including a vial (body 1005; [0055]; Fig. 10) with a first sorbent (item 1040 in Fig. 10) bonded to an interior surface of a closed bottom portion of the vial (the sorbent materials can be chemically bonded to the inner surface of the body of the sorbent device; [0048])(Fig. 10 shows sorbent 1040 disposed at the bottom portion of the vial, sampling outlet 1020, which is “closed or sealed” ([0055][0036]),
the sampling device configured to diffusively collect (using “internal, longitudinal diffusion path to permit passive sampling of samples that include a plurality of species having varying boiling points”; [0033];[0002]) an air sample (drawing a sample of gas (typically ambient air; [0033]) for chemical analysis by gas chromatograph following thermal desorption or solvent extraction (“the sorbent device having the adsorbed analytes is subsequently heated in a thermal desorption instrument, and a flow of inert gas, such as helium, nitrogen or hydrogen, is provided to sweep the VOCs out of the sorbent device and into a chromatographic column for separation and analysis,” as a part of a “gas chromatography system”; [0033];[0067]), and
a cap configured to couple to the sampling device to seal the sampling device (After the species are adsorbed, the sampling inlet 110 can be capped or covered; [0038]),
a preconcentration device (thermal desorption analyzer; [0011]), coupled to the sampling device via an opening of the sampling device (“coupling the sorbent device to a thermal desorption analyzer,” wherein the thermal desorption analyzer is coupled to the open base of the sampling device; Tipler, [0011],[0036]; See base 1020 of Fig. 10).
Tipler is silent to teaching the first sorbent includes an adhesive surface, the sampling device has an inert cap (Emphasis added), the sampling device is compatible with solvent extraction, coupling an opening of the cavity to an opening of the sampling device, and a vacuum source, coupled to the preconcentration device.
Spero teaches the first sorbent includes an adhesive surface (“micro posts 122 are pre-functionalized with avidin end groups,” wherein “adhesion between silica and PDMS can be used to attach silica capture beads to PDMS micro posts”; [00164][0087]; See Fig. 12).
Spero is considered to be analogous to the claimed invention because it is in the same field of endeavor for sorbent-based collection of analytes in air samples (Spero, [0062]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first sorbent layer (1040 in Fig. 13 of Tipler) taught by Tipler to incorporate the adhesive surface taught by of Spero in order to stabilize the stacked sorbent layers. Tipler already relies on stacked sorbent beds arranged by strength for capturing species of varying boiling points while the beds are packed together during use ([0038][0054]). The material of the different sorbent layers can be PDMS and fused silica beads (Tipler, [0062][0063]). Likewise, Spero teaches two layers of sorbent material but also teaches an adhesive surface on the PDMS layer in order to bind with the next layer of silica beads ([00165][00850; Fig. 12). PDMS-based adhesion is a known technique in the art that would predictably stabilize the first layer, reduce bead migration, and maintain a consistent diffusion path (Tipler, “825 between the walls of the body 805 of the sorbent device 800 and the packed sorbent materials 830-840”; [0054]; Fig. 8) resulting in an improved system (See MPEP 2143(I)(A)).
Modified Tipler is silent to teaching the sampling device has an inert cap (Emphasis added), the sampling device is compatible with solvent extraction, coupling an opening of the cavity to an opening of the sampling device, and a vacuum source, coupled to the preconcentration device.
Mengel teaches an inert cap (caps are made of inert material; column 5, line 28-30; Fig. 3)
Mengel is considered to be analogous to the claimed invention because it is in the same field of endeavor for collecting volatile samples (Trapping Contaminants Contained In A Gas; Title). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the generic cap taught by Tipler in view of Spero with the inert cap taught by Mengel so “that there is essentially no chance of interaction between sample constituents and the cap material” (Mengel, column 5, line 28-30; Fig. 3). One of ordinary skill in the art would have recognized that applying this known technique would have yielded predictable results and resulted in an improved system (See MPEP 2143(I)(D)).
Modified Tipler is silent to teaching that the sampling device is compatible with solvent extraction, coupling an opening of the cavity to an opening of the sampling device, and a vacuum source, coupled to the preconcentration device.
Cardin teaches a sampling device that is compatible with solvent extraction (sample extraction device…can be used to extract samples…using a solvent; [0039]) and a vacuum source, coupled to the preconcentration device (“a vacuum source can be coupled to the sample extraction device 100 at the valve end 214,” while “creating a vacuum to increase recovery of low volatility compound”;[0028], Abstract).
Cardin is considered to be analogous to the claimed invention because it is in the same field of endeavor of sorbent-based collection of volatile/semivolatile chemicals for chromatographic analysis ([0047][0054]). Solvent extraction only requires that a solvent contacts a sorbent and dissolves an analyte. Both Tipler and Cardin use the same solvent material of Tenax (Tipler, [0062]; Cardin, [0027]), and Tipler even states that the sorbent is bonded to the inner surface body using the same technique for manufacturing solid phase micro extraction columns ([0048]). Additionally, Tipler teaches “that fluid is permitted to diffuse into the device through the sampling inlet” to desorb analytes ([0036]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specified the sorbent device taught by Tipler in view of Spero and Mengel to be compatible with solvent extraction as taught by Cardin as well as coupling a vacuum source to the preconcentration device in order to facilitate sample transfer. Doing so would enable the device to “extract samples that are better recovered using a solvent, rather than via thermal desorption prior to GC or GCMS” and even “LC and/or LCMS” (Cardin, [0039]). Implementing the known alternative of solvent addition when using the device taught by Tipler is a combination of elements according to known methods to yield predictable results, since either method (thermal desorption or solvent extraction) would merely function as it does separately (See MPEP 2143(I)(A)).
Modified Tipler is silent to teaching coupling an opening of the cavity to an opening of the sampling device and a vacuum source, coupled to the preconcentration device.
Psyllaki teaches coupling an opening of the cavity to an opening of the sampling device (coupling the closure device equipped with an internal seal to a sample vial; claim 4)(See Figs. 2-3)
Psyllaki is considered to be analogous to the claimed invention because it is in the same field of endeavor for diffusive gas sampling. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling relationship between the sampling device and the preconcentration device taught by Tipler in view of Spero, Mengel, and Cardin to incorporate the teachings of Psyllaki by coupling the openings of the devices together. Reference Cardin teaches the use of a sorbent pen as the extraction device and aims to “reduce condensation and/or humidity at the sample extraction device” ([0048]). Psyllaski teaches that doing so would speed kinetics under vacuum ([0009]), control humidity via a hot-vial/cool-trap thermal gradient ([0010]), gain standardized, automated coupling ([0022]), and reach equilibrium faster ([0020]), which are all predictable improvements supported by the vacuum headspace art. Therefore, one of ordinary skill in the art would expect the substitution to yield predictable results and an improved system (See MPEP 2143(I)(C)).
Regarding claim 11, The system of claim 10, wherein the sampling device further includes a second sorbent (item 1038 in Fig. 10 of Tipler) bonded to the adhesive surface of the first sorbent (adhesion between silica and PDMS can be used to attach silica capture beads to PDMS micro posts,” by “using a chemical bond”; Spero, [0087]; Fig. 12).
Regarding claim 12, The system of claim 10, further comprising:
a heater configured to apply more heat to the first sorbent than to the third sorbent.
Modified Tipler instead teaches one or more compounds are transferred to a cooled secondary trap (cavity), when the sampling device is heated ([0067]).
Cardin teaches a heater (using a heater; [0048]).
Cardin is considered to be analogous to the claimed invention because it is in the same field of endeavor for sorbent-based collection of volatile/semivolatile chemicals for chromatographic analysis ([0047][0054]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the diffusive sampling system taught by Tipler in view of Spero, Mengel and Cardin to further incorporate the teachings of Cardin by including a a heater as means for heating the first and third sorbents. There are only a finite number of identified solutions for heating the sorbent device as taught by Tipler ([0033]) and doing so represents a predictable solution with a reasonable expectation of success (See MPEP 2143(I)(A and E)).
Modified Tipler fails to teach that more heat is applied to the first sorbent than to the third sorbent.
However, paragraphs [0034] and [0048] of Cardin teach varying the temperature, vacuum, and cycling conditions between the vial and the sample extraction device, and the “sample extraction device heating can be omitted,” while “heating the sample can cause an aqueous solution to boil (The sample extraction device containing the third sorbent, and the sample being attached to the first sorbent; See [0048]). These parameters are result-effective variables used to achieve maximum sample extraction based on the volatility of the compounds of interest which may be achieved by applying more heat to the first sorbent than to the third sorbent (See MPEP 2144.05(II)). One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to adjust relative temperatures between sorbent regions or optimize heating intensity by applying more heat to the first sorbent than to the third sorbent to achieve predictable improvements in analyte transfer (See MPEP 2143(I)(D)).
Regarding claim 13, The system of claim 12, wherein the preconcentration device further includes a valve (valve end 214; Cardin, [0028]; Fig. 2B), and while the valve is closed (sealing plunger 204 can be depressed to open the top of the valve; Cardin, [0029]; Fig. 2B) and the sampling device is coupled to the preconcentration device, the system is a closed system (after the sample has been collected by the sample extraction device 200, the sealing plunger 204 can be remain closed…and can isolate the sample from the environment, allowing the sample to be stored in the sample extraction device 200; Cardin; [0029]; Fig. 2B).
Regarding claim 14, The system of claim 12, wherein the preconcentration device further includes a valve and the vacuum source is configured to a draw a vacuum in the preconcentration device and the sampling device (while the sample extraction device 200 is inserted into sample vial 250, a vacuum can be pulled in sample vial 250 through the sample extraction device 200; Cardin, [0032]) while the vacuum source is coupled to the valve of the preconcentration device (a vacuum source can be coupled to the sample extraction device 100 at the valve end 214; Cardin, [0028]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Tipler et al. (US 20100242579 A1) in view of Spero (US 20220395834 A1, filing date 2020-11-16), Mengel et al. (US 6244117 B1, 2001), Cardin (WO 2018013946 A1; see attached English translation), and Psyllaki (US 20210156768 A1, filing date 2020-11-20), as applied to claim 12 above, and in further view of Bouvier (US 20170282096 A1).
Regarding claim 15, The system of claim 12,
Modified Tipler fails to teach a vacuum sleeve, wherein the preconcentration device is disposed inside the vacuum sleeve while the preconcentration device is coupled to the sampling device.
Bouvier teaches a preconcentration device disposed inside the vacuum sleeve (vacuum insulated jacket surrounds the chromatography column; [0005]) while the preconcentration device is coupled to the sampling device (the vacuum sleeve is functionally capable of encasing the preconcentration device while the preconcentration device is coupled to the sampling device)
Bouvier is considered to be analogous to the claimed invention because it is in the same field of endeavor for desorption of volatile and semi-volatile analytes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample extraction device taught by Tipler in view of Spero, Mengel, and Cardin to incorporate the teachings of Bouvier by including a vacuum jacket around the sample extraction device. It is known in the field of separation chromatography that the use of a vacuum jacket yields an insulating effect while the extraction process proceeds within the separation device. Cardin identifies condensation and analyte loss as a problem when attempting to maintain the sampling path at a controlled temperature to preserve volatile components ([0048]). Bouvier teaches surrounding a device with a vacuum jacket to thermally insulate the internal flow path, thereby reducing heat loss and preventing condensation during the transfer of analytes (90072]). One of ordinary skill in the art would have found it obvious to use the vacuum-jacketed insulation taught by Bouvier around Cardin’s sample extraction device by applying a known technique to a similar device to yield predictable results (See MPEP 2143(I)(A)).
Conclusion
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.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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