DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Species A (barrier is integral with the substrate, FIG. 1) in the reply filed on 22 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3, 13, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 4 is treated as being dependent from claims 1 or 2 due to the withdrawal of claim 3. Claim 14 is treated as being dependent from claims 11 or 12 due to the withdrawal of claim 13.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 17 and 19 are objected to because of the following informalities: “applying a desorption solvent to device” should read “applying a desorption solvent to a device”. Appropriate correction is required.
Claims 5-10 and 15-18 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
Claim Interpretation
Claim 11 recites the limitation “a substantially horizontal orientation”. In accordance with paragraph 0039 of the present specification, “substantially horizontal” is interpreted to mean that “the surface is positioned in an orientation where a desorption solvent placed on the surface of the substrate does not move due only to gravity”.
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 1-2, 4, 11-12, and 14 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.
Claims 1 and 11 recite the limitation "the solvent". There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the Examiner has interpreted “the solvent” to mean “the desorption solvent”. Claims 2, 4, 12, and 14 are rejected because of their dependence on claims 1 and 11.
Claims 2 and 12 recite the limitation "the barrier". There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the Examiner has interpreted “the barrier” to mean “the fluid barrier”. Claims 4 and 14 are rejected because of their dependence on the rejected claims.
Claim 11 recites the limitation "the formed ions" in line 13. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the Examiner has interpreted “the formed ions” to mean “the expelled ionized molecules”.
Regarding claims 4 and 11, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, the Examiner has interpreted the claims as follows:
Claim 4: “…wherein the substrate is at least a two-sided substrate and the device comprises a fluid barrier on each side.”
Claim 11: “…holding the substrate in a substantially horizontal orientation
Claim 12 is rejected because of its dependence on claim 11.
The terms “about” and “for example” in claim 11 are relative terms which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention; and it is unclear whether the limitation(s) following the phrase “for example” are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, the Examiner has interpreted claim 11 as follows:
“…applying a desorption solvent to the substrate
Claim 12 is rejected because of its dependence on claim 11.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “an absolute pitch angle of less than 15°”, and the claim also recites “such as less than 10°, less than 5° or about 0°” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 11, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Pawliszyn et al. (U.S. Patent Application Publication No. 2021/0257204 A1), hereinafter Pawliszyn (2021).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Pawliszyn (2021) discloses a device for generating ionized molecules of interest for analysis in a mass spectrometer (paragraph 0014), wherein the molecules of interest are desorbed from the device into a desorption solvent (paragraph 0027), the device comprising:
a solid substrate (FIG. 19, element 1910) having a spray-ionization (paragraphs 0014-0015) end (FIG. 19, element 1912) and a holding end (FIG. 19, flat end of substrate 1910, opposite tip 1912), the substrate sized and configured to hold the solvent at the spray-ionization end (paragraph 0190); and
a fluid barrier configured to reduce movement of at least some of the solvent from the spray-ionization end towards the holding end (Dictionary.com defines ‘barrier’ as ‘anything that restrains or obstructs progress, access, etc.’; paragraph 0188 discloses “a channel 1916 for channeling desorption solution…toward tip 1912”, and paragraph 0190 discloses “a slope to lead by gravity the desorption solution containing the molecules of interest toward tip 1912”; the channel and/or the slope are both configured to obstruct the fluid’s access to the holding end of the substrate by directing the fluid toward tip 1912; therefore, the channel and/or slope constitute fluid barriers).
Regarding claim 2, Pawliszyn (2021) as applied to claim 1 discloses the device according to claim 1.
In addition, Pawliszyn (2021) discloses that the barrier is integral with the substrate (FIG. 19: the channel 1916 is formed in the substrate 1910; paragraph 0190: the substrate 1910 is shaped to form the slope which constitutes the fluid barrier).
Regarding claim 11, Pawliszyn (2021) discloses a method for analyzing molecules previously extracted from a sample and adsorbed onto a solid substrate (paragraph 0127, last sentence), the substrate comprising a spray-ionization end (FIG. 6, tip 612), a holding end (FIG. 2A: the end of the substrate opposite the pointed tip, i.e., tip 612 of FIG. 6, is held in a holder 202), a fluid barrier between the spray-ionization end and the holding end (FIG. 6, fluid barrier formed by the walls of indentation 614 and channel 616), wherein the extracted molecules are adsorbed on an extraction portion of the substrate between the fluid barrier and the spray-ionization end (FIG. 6, extraction portion 688), the method comprising:
holding the substrate in a substantially horizontal orientation, such as an orientation with an absolute pitch angle of less than 15°, such as less than 10°, less than 5°, or about 0° (FIGs. 2A, 2B show substrate 210 held in a horizontal orientation in multiple perspectives);
applying a desorption solvent to the substrate, for example applying from about 5 μL to about 15 μL of the solvent (paragraph 0127);
desorbing molecules from the substrate (paragraph 0127);
ionizing the desorbed molecules using an ionization source to expel ionized molecules from the spray-ionization end of the substrate (paragraph 0027); and
analyzing the formed ions by mass spectrometry (paragraph 0027),
wherein the fluid barrier is configured to reduce movement of at least some of the desorption solvent from the spray-ionization end to the holding end (Dictionary.com defines ‘barrier’ as ‘anything that restrains or obstructs progress, access, etc.’; paragraph 0127 discloses “a compartment 614…for receiving desorption solution, and/or a channel 616 for channeling desorption solution…toward tip 612”; the compartment and channel are both configured to obstruct the fluid’s access to the holding end of the substrate by directing the fluid toward tip 612; therefore, the compartment and channel constitute fluid barriers).
Regarding claim 12, Pawliszyn (2021) as applied to claim 11 discloses the method according to claim 11.
In addition, Pawliszyn (2021) discloses that the barrier is integral with the substrate (FIG. 6: compartment 614 and channel 616 are formed in the substrate 610a).
Regarding claim 14, Pawliszyn (2021) as applied to any one of claims 11 to 12 discloses the method according to any one of claims 11 to 12.
In addition, Pawliszyn (2021) discloses that the ionization is negative ionization and/or wherein the mass spectrometry is electrospray ionization (paragraph 0115).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pawliszyn (2021) as applied to any one of claims 1 to 2 above, in view of Pawliszyn et al. (U.S. Patent Application Publication No. 2017/0254729 A1), hereinafter Pawliszyn (2017).
Regarding claim 4, Pawliszyn (2021) as applied to any one of claims 1 to 2 discloses the device according to any one of claims 1 to 2.
In addition, Pawliszyn (2021) discloses that the substrate is at least a two-sided substrate (FIG. 6, upper and lower sides of substrate 610a).
Pawliszyn (2021) fails to disclose that the device comprises a fluid barrier on each side.
However, Pawliszyn (2017) discloses that the device comprises a fluid barrier (paragraph 0098, lines 27-28) on each side (paragraph 0099, lines 1-2; FIG. 4B, protrusions 404).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Pawliszyn (2021) to include that the device comprises a fluid barrier on each side, based on the teachings of Pawliszyn (2017) that the plurality of barriers increase the strength of the substrate to prevent breakage, and the plurality of barriers also improve the resolution of analyte concentration gradients by preventing undesirable fluid diffusion (Pawliszyn, paragraph 0098).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dulay et al. (U.S. Patent Application Publication No. 2022/0181136 A1), hereinafter Dulay, teaches a device for generating ionized molecules of interest for analysis in a mass spectrometer, the device comprising a solid substrate having an end sized and configured to hold a solvent and a fluid barrier configured to reduce movement of at least some of the solvent, wherein the substrate and the barrier are configured and positioned to hold at least 5 μL of the solvent; and wherein the barrier extends at least 0.5 mm above the surface of the substrate.
Pawliszyn et al. (U.S. Patent Application Publication No. 2021/0156767 A1), hereinafter Pawliszyn (2021A), teaches a device comprising a previously-etched stainless-steel substrate comprising a tip having a substantially triangular shape being defined by at least two edges that meet at an angle from about 8 degrees to about 90 degrees; the substrate having an average thickness that is from about 0.01 mm to about 2 mm; a length from about 1 cm to about 10 cm; and a width from about 0.1 to about 5 mm; the device further comprising an extractive phase coating, such as a solid phase microextraction (SPME) coating, on at least a portion of the surface of the substrate, and comprises a sealing layer between the extractive phase coating and the substrate, wherein the sealing layer lacks any extractive phase material.
Pawliszyn et al. (U.S. Patent Application Publication No. 2015/0318160 A1), hereinafter Pawliszyn (2015), teaches a device for generating ionized molecules of interest for analysis in a mass spectrometer, wherein the molecules of interest are desorbed from the device into a desorption solvent, the device comprising: a solid substrate having a spray-ionization end and a holding end, the substrate sized and configured to hold the solvent at the spray-ionization end; and a fluid barrier configured to reduce movement of at least some of the solvent from the spray-ionization end towards the holding end, wherein the device further comprises a substrate holder configured to engage the holding end of the substrate, the substrate holder comprises the barrier, and the barrier abuts the substrate when the substrate holder engages the holding end of the substrate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at (571)272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.K./Examiner, Art Unit 2881
/ROBERT H KIM/Supervisory Patent Examiner, Art Unit 2881