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 Abstract submission dated 06/24/2026 has overcome the previous Abstract objection.
Applicant’s arguments filed 06/24/2026 indicate that a replacement ADS is provided to correct the inconsistencies between the specification and the ADS dated 11/27/2023 (see pp. 3-4 of the prior Office Action); however, the Examiner could not locate the replacement ADS in the application contents and therefore the previous Specification objection is maintained.
Applicant's arguments filed 06/24/2026 regarding the previous prior art rejections have been fully considered but they are not persuasive. Applicant has argued that Yang et al. (Paper spray ionization devices for direct, biomedical analysis using mass spectrometry) does not disclose or suggest the limitation of wherein the product further comprises an electrode as a part of the top portion of the cartridge such that the electrode extends through the top portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge, as required by the amendment to independent claim 19, and Applicant alleges that Yang et al. in fact teaches away from this limitation.
As discussed in the prior Office Action, Yang et al. discloses a cartridge comprising a top portion and a bottom portion. In the prior Office Action, the Examiner acknowledged that Yang et al. discloses wherein the electrode is installed in the bottom portion rather than the top portion. However, the Examiner asserts that rearrangement of parts of a prior art device, wherein the rearrangement does modify the operation of the device, is an obvious matter of design choice (MPEP §2144.04). Specifically, Yang et al. discloses wherein the electrode is a part of the bottom portion of the cartridge such that the electrode extends through the bottom portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge (p. 10 para. 2-p. 11 para. 1) (Fig. 4, p. 9; Fig. 5, p. 10). Modifying the product disclosed by Yang et al. such that the electrode is a part of the top portion of the cartridge such that the electrode extends through the top portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge would require mere rearrangement of parts, namely, by installing the electrode on the top portion rather than on the bottom portion as is disclosed by Yang et al. Such a modification would not modify the operation of the device, as installing the electrode in the top portion would still allow the electrode to apply an electrical field to the substrate. Furthermore, the skilled artisan would have been motivated to arrange the electrode in the top portion to allow a user to easily inspect the electrode from above. Therefore, although Yang et al. does not anticipate the limitation, the limitation is obvious in view of Yang et al. As to Applicant’s argument that Yang et al. teaches away from the limitation, this is found unpersuasive because Yang et al. does not “criticize, discredit, or otherwise discourage” installing the electrode on the top portion rather than the bottom portion (MPEP §2145).
The claim amendments have necessitated a new grounds of rejection.
Specification/Priority
There appear to be inconsistencies between the Specification and the Application Data Sheet (ADS).
The specification states that the present is continuation of U.S. nonprovisional application serial number 17/841,141; however, the ADS dated 11/27/2023, which appears to be the only ADS of record, states that the present application is a continuation in part of 17/841,141.
The specification states a chain of priority going back to U.S. nonprovisional application serial number 13/926,645, filed June 25, 2013; however, the ADS dated 11/27/2023 claims benefit to additional earlier applications.
In any case, the 13/926,645 application appears to be the earliest application that provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for each and every limitation of independent 19 of this application, from which all other claims depend, and therefore this application is afforded an effective filing date of June 25, 2013.
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 19-25 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.
Claim 19 has been amended to recite a method comprising the steps of “providing a product…; contacting the porous substrate when the porous substrate is held in the cartridge; and moving air or liquid through the exposed portion of the porous substrate such that any target analyte in the air or liquid is retained and captured by the porous substrate.” The amendment renders the claim indefinite as it is unclear what is encompassed by the “contacting the porous substrate when the porous substrate is held in the cartridge” step. The specification indicates that the method comprises “contacting a sample to the porous material” (see p. 4 of the 02/27/2024 specification); however the specification also indicates that the sample is contacted to the porous substrate by moving air or liquid over the porous substrate (see p. 37 of the 02/27/2024 specification). Therefore, it is unclear how the “contacting the porous substrate” step and the “moving air or liquid” step of claim 19 could be two separate steps.
Claim 25 recites “wherein the electrode is associated with the top portion of the cartridge.” However, claim 19, from which claim 25 depends, has been amended to recite “wherein the product further comprises an electrode as a part of the top portion of the cartridge such that the electrode extends through the top portion of the cartridge”, which would encompass the electrode being “associated” with the top portion of the cartridge. Therefore, the metes and bounds of claim 25 are unclear as it is unclear how claim 25 further limits the subject matter of claim 19.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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.
Claims 19, 21-23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Paper spray ionization devices for direct, biomedical analysis using mass spectrometry) (already of record).
Regarding claim 19, Yang et al. discloses a method for capturing a target analyte from a sample (Abstract, p. 10 para. 2-p. 11 para. 1), the method comprising:
providing a product comprising a capture module configured to capture a target analyte from a sample (Abstract, p. 10 para. 2-p. 11 para. 1), wherein the capture module comprises a porous substrate that is held between a top and bottom portion of a cartridge (Abstract, p. 10 para. 2-p. 11 para. 1) (Fig. 5, p. 10), the top and bottom portion sandwiching the porous substrate and each having an opening therein such that a portion of the porous substrate is exposed when the porous substrate is held in the cartridge (p. 10 para. 2-p. 11 para. 1) (Fig. 5, p. 10), wherein the product further comprises an electrode as a part of the bottom portion of the cartridge such that the electrode extends through the bottom portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge (p. 10 para. 2-p. 11 para. 1) (Fig. 4, p. 9; Fig. 5, p. 10);
contacting the porous substrate when the porous substrate is held in the cartridge (p. 10 para. 2-p. 11 para. 1) (Fig. 5, p. 10); and
moving liquid through the exposed portion of the porous substrate such that any target analyte in the liquid is retained and captured by the porous substrate (Abstract, p. 10 para. 2-p. 11 para. 1).
Yang et al. discloses wherein the electrode is a part of the bottom portion of the cartridge such that the electrode extends through the bottom portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge, rather than wherein the electrode is a part of the top portion of the cartridge such that the electrode extends through the top portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge.
Nonetheless, it has been held that the rearrangement of parts of a prior art device, wherein the rearrangement does modify the operation of the device, is an obvious matter of design choice (MPEP §2144.04). Modifying the product disclosed by Yang et al. such that the electrode is a part of the top portion of the cartridge such that the electrode extends through the top portion of the cartridge to contact a rear portion of the porous substrate when the porous substrate is held in the cartridge would require mere rearrangement of parts, namely, by installing the electrode on the top portion rather than on the bottom portion as is disclosed by Yang et al. Such a modification would not modify the operation of the device, as installing the electrode in the top portion would still allow the electrode to apply an electrical field to the substrate. Furthermore, the skilled artisan would have been motivated to arrange the electrode in the top portion to allow a user to easily inspect the electrode from above. Therefore, the noted limitation is obvious in view of Yang et al.
Regarding claim 21, the limitation “wherein the porous substrate is discrete from a flow of solvent” is understood to mean wherein the porous substrate is separate or disconnected from a flow of solvent, or wherein a discrete amount (e.g. a drop or droplets) of solvent is applied to the porous substrate, consistent with Applicant’s specification (see p. 3 of Specification). In any case, Yang et al. fulfills the limitation, because Yang et al. discloses wherein a small volume of solvent is sprayed onto the substrate (Abstract) (thus the substrate is not in direct connection with a flow of solvent; rather, a small amount of solvent is sprayed onto the substrate), wherein the amount is discrete, e.g. 10 µL (Abstract).
Regarding claim 22, Yang et al. discloses wherein the porous substrate tapers to at least one distal tip (p. 10 para. 2-p. 11 para. 1) (Fig. 5, p. 10).
Regarding claim 23, Yang et al. discloses wherein the method comprises applying a solvent to the porous substrate (p. 10 para. 2-p. 11 para. 1) (Fig. 5, p. 10). As to the limitation of “wherein optionally, the solvent comprises an internal standard”, this is an optional limitation and therefore does not introduce a patentable distinction over the prior art.
Regarding claim 25, it would have been obvious to one of ordinary skill in the art to modify the product disclosed by Yang et al. such that the electrode is a part of the top portion of the cartridge (reads on “associated” with the top portion of the cartridge), as set forth in the rejection of claim 19, above.
Claims 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Paper spray ionization devices for direct, biomedical analysis using mass spectrometry) (already of record) in view of Zhang et al. (Rapid direct lipid profiling of bacteria using desorption electrospray ionization mass spectrometry) (already of record).
Regarding claim 20, Yang et al. discloses wherein the liquid comprises a biological sample (p. 10 para. 2-p. 11 para. 1). Yang et al. envisions that the method “is suitable for fast clinical analysis, especially for point-of-care diagnostics” (Abstract). The method comprises conducting electrospray ionization to generate ions for mass spectrometry analysis (Abstract).
Yang et al. is silent as to wherein the liquid comprises a plurality of unknown microorganisms.
Zhang et al. discloses a method comprising applying an electrospray ionization technique to a liquid sample comprising a plurality of bacteria so as to identify different bacteria species in the sample (Abstract, p. 38 col. 1 para. 3-p. 40 col. 1 para. 1). Zhang et al. discloses that the identification of bacteria species is important for biosafety and medical purposes (p. 37 col. 1 para. 1).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Yang et al. such that the liquid comprises a plurality of unknown microorganisms, because the skilled artisan would have been motivated to apply the method of Yang et al. to a sample containing unknown microorganisms, e.g., a biological sample of a patient suspected to be infected with an infectious disease, for the purposes of diagnoses and/or biosafety, based on the teachings of Yang et al. and Zhang et al.
Regarding claim 24, Yang et al. discloses wherein the liquid comprises a biological sample (p. 10 para. 2-p. 11 para. 1). Yang et al. envisions that the method “is suitable for fast clinical analysis, especially for point-of-care diagnostics” (Abstract). The method comprises conducting electrospray ionization to generate ions for mass spectrometry analysis (Abstract).
Yang et al. is silent as to wherein the target analyte is a microorganisms selected from the group consisting of a bacterium, a virus, a protozoan, and a fungus.
Zhang et al. discloses a method comprising applying an electrospray ionization technique to a liquid sample comprising a target analyte comprising a bacterium so as to identify the presence of the bacterium in the sample (Abstract, p. 38 col. 1 para. 3-p. 40 col. 1 para. 1). Zhang et al. discloses that the identification of bacteria is important for biosafety and medical purposes (p. 37 col. 1 para. 1).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the method disclosed by Yang et al. such that the liquid comprises a target analyte that is a bacterium, because the skilled artisan would have been motivated to apply the method of Yang et al. to a sample containing a bacterium, e.g., a biological sample of a patient suspected to be infected with an infectious disease, for the purposes of diagnoses and/or biosafety, based on the teachings of Yang et al. and Zhang 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 HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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