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 with respect to claim(s) 1, 3, 4, 8, 9, 12-19, and 31 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed July 15, 2026 have been fully considered but they are not persuasive. Applicant has amended independent claim 1 to recite a housing having a second chamber, and a stationary phase movably disposed between an extraction chamber and the second chamber, and argued that the claims are in condition for allowance. The Examiner respectfully disagrees and contends that reference to Markovsky still meets the claim limits. As detailed in the previous Office Action, reference to Markovsky teaches a sampling device comprising a housing and a stationary phase configured to be moved within the housing. Markovsky also teaches the housing having a plurality of reagent chambers wherein the stationary phase can be moved into each of the reagent chambers (paragraph 0051). The Examiner also notes that claim 1 recites a conditional limitation that is not required to occur, and therefore does not impart structure to the device. Applicant has also argued that reference to Markovsky does not teach an extraction chamber having an inlet and therefore does not teach the claim limitations. Here, the Examiner points to figure 8 of Markovsky which shows the extraction chamber (#12) having an opening in which the stationary phase enters the chamber (figure 8 #’s 4, 12). Therefore, in light of the teachings of the prior art, and the arguments provided here, the Examiner contends that the limitations of the instant claims are taught by reference to Markovsky, thus the claims are not in condition for allowance.
Election/Restrictions
Newly submitted claims 33 and 34 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 33 recites an extraction device that requires a membrane at an exterior of the extraction chamber, which is not required by the extraction device of claim 1. As such, claim 33 is distinct from claim 1.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 33 and 34 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
For claim 1, the phrase “when the stationary phase is disposed within the extraction chamber” is a conditional limitation as the stationary phase is not required to be disposed in the extraction chamber. As such, anything that occurs after “when” is also conditional and does not impart structure to the claim.
For claim 3, the Examiner notes that the term “portion” does not indicate a specific element of the stationary phase, and contends that any part of the stationary phase can be considered as a “portion” of a substrate.
For claim 8, the Examiner notes that it is unclear what structural elements are recited in the claim as the sampling space is not a structural element of the claimed device. Additionally, the chemical analyzer is not a structural element of the device, thus the substrate being coupled to the chemical analyzer does not limit the structure of the claimed device.
For claims 1, 3, 4, 8, 9, 12-19, and 31, the Examiner notes that the phrases “for containing,” “for delivering,” and “configured to” are being read as intended use limitations, and any prior art device capable of performing the claimed functions will be read as meeting the claim limitations.
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.
Claim 9 is 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.
For claim 9, the phrase “the stationary phase being moved to the elution chamber for desorbing said one or more analytes adsorbed to the stationary phase into the elution solvent” is a process limitation in a claim directed to a device which renders the claim indefinite (MPEP 2173.05(p). As set forth in the MPEP, a process limitation in a claim directed to a device is indefinite as it is unclear whether infringement occurs when one makes the claimed device, or if infringement only occurs when the device is utilized in the manner recited in the claim. As such, for claim 9, it is unclear if infringement occurs when one makes the claimed device or if infringement only occurs when the device is utilized in the manner recited in the claim.
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) 1, 3, 4, 8, 31, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markovsky (US 2010/0136670).
For claim 1, Markovsky teaches a sampling device comprising a housing defining a test unit body (extraction chamber, paragraph 0041, figure 1 #12) having an inlet (figure 8, opening at top of #12), a plurality of reagent chambers (second chamber, paragraphs 0040, 0047, 0049, 0051), a stationary phase configured to be moved into the reading chamber (paragraphs 0042, 0047, figure 14 #4), wherein the stationary phase is movably disposed between the test unit body and the reagent chambers (paragraphs 0042, 0047, 0049, 0051), and wherein the stationary phase can be attached to a chemical analyzer (paragraph 0048, figure 15).
For claim 3, Markovsky teaches the adsorbent material being attached to a probe (substrate, paragraph 0043). The Examiner notes that the term “portion” does not identify a specific part of the stationary phase, and is sufficiently broad so as to read on the entire stationary phase.
For claim 4, the Examiner notes that the chemical analyzer is not a structural element of the claimed device, and therefore is not given patentable weight.
For claim 8, Markovsky teaches the probe capable of being moved into a liquid (paragraph 0047). The Examiner notes that the adsorbent material of Markovsky is attached to a probe (substrate) thus moving the adsorbent material into a liquid necessarily requires the probe to be moved into the liquid. Additionally, the Examiner notes that the capture liquid and sampling space are not structural elements of the claimed device, and therefore are not considered with respect to patentability.
For claims 31 and 32, Markovsky teaches the housing comprising a plurality of reagent chambers wherein the stationary phase pierces a membrane on each of the reagent chambers to gain access to the chamber (paragraphs 0051, 0052).
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.
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(s) 9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky (US 2010/0136670).
Regarding claims 9 and 12-15, Markovsky teaches an extraction device comprising a plurality of sealed reagent chambers wherein the reagent chambers are configured to hold a variety of reagents (paragraph 0052) in solid or liquid forms (paragraph 0041). Markovsky does not explicitly teach an elution chamber, washing chamber, and conditioning chamber; however, the Examiner notes that the structure of the reagent chambers taught by Markovsky are identical to the structure of the claimed chambers, thus the reagent chambers of Markovsky would be capable of containing an elution solvent, washing buffer, and conditioning solvent. Additionally, Markovsky teaches that it is advantageous to provide a plurality of reagent chambers as a means of allowing additional reagents or reagent combinations to be contained within the extraction device (paragraph 0052). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Markovsky to provide an elution chamber, washing chamber, and conditioning chamber in order to allow for additional reagents or reagent combination to be contained within the extraction device as taught by Markovsky.
Regarding claim 16, Markovsky teaches the chambers being sized to hold a variety of quantities or volumes (paragraph 0052), but do not explicitly teach the chambers containing less than about 100 microliters. The Examiner is reading this limitation as a change in size or proportion which would have been obvious to one of ordinary skill in the art (MPEP 2144.04 IV A). The MPEP states that where the only difference between the prior art and the claims is a recitation of relative dimensions, and a device having the claimed relative dimensions would not perform different than the prior art device, the claimed device is not patentably distinct from the prior art. Reference to Markovsky teaches that the chambers can be sized to hole a variety of volumes, thus one of ordinary skill in the art would have found it obvious to size the chambers to hold 100 microliters as recited in claim 16. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Markovsky wherein the chambers are sized to contain less than 100 microliters as changes in size/proportion require only routine skill in the art.
Claim(s) 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Markovsky (US 2010/0136670) in view of Wells et al., (US 2012/0160038).
Regarding claims 17-19, Markovsky does not teach a fluid flow pathway comprising a lumen.
Wells et al., teach a solid phase extraction device wherein an adsorbent material is contained within a needle (paragraph 0003). Wells et al., teach that it is advantageous to utilize a needle as a means of protecting a fragile adsorbent material (paragraph 0003).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Markovsky wherein an adsorbent material is contained within a needle in order to protect a fragile adsorbent as taught by Wells et al.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAN A GERIDO/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
