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 without traverse of Group I, claims 21-29, in the reply filed on 05/19/2026 is acknowledged.
Claims 30-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15547786, filed on 08/01/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/27/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 132a-c and 132 (mentioned in section “1.3.4 Blister sub-assembly”, wherein “Figure 5 shows the blister sub-assembly”; however these reference signs could not be located in Fig. 5). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 21 recites: A fluidic cartridge for carrying out a diagnostic test on a sample contained therein, the cartridge comprising more than one collapsible blister, each blister containing at least one reagent and configured to be collapsed by a blister actuator, at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile (emphasis added). The emphasized portion of the claim has been interpreted as meaning each blister contains at least one reagent, each blister is configured to be collapsed by a blister actuator, each blister is configured to be collapsed by at least one blister actuator having a substantially flat profile, and each blister is configured to be collapsed by at least one blister actuator having an outwardly extending curved profile, consistent with Applicant’s specification (see “1.3.4 Blister sub-assembly 112” and “2.6 Blister and valve actuation”). It is noted that claim 21 is directed to a fluidic cartridge whereas Applicant’s specification indicates that any blister actuator is a component of the cartridge reader rather than the fluidic cartridge (see “1.3.4 Blister sub-assembly 112” and “2.6 Blister and valve actuation”). Therefore any claimed blister actuators have been interpreted in terms of an intended use of the fluidic cartridge rather than as positively recited structural elements of the fluidic cartridge.
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.
Claims 21-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agarwal et al. (US Patent Application Publication 2013/0302787).
Regarding claim 21, Agarwal et al. discloses a fluidic cartridge (Abstract, para. 2, 7) for carrying out a diagnostic test on a sample contained therein (para. 187-188), the cartridge comprising more than one collapsible blister (para. 70, 152), each blister containing at least one reagent (para. 70, 74) and configured to be collapsed (para. 152).
As to the limitation of each blister configured to be collapsed by a blister actuator, at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile, Agarwal et al. discloses wherein each blister comprises a convex structure bulging from a top outer surface of the cartridge (Fig. 1, sheets of 13) and is configured to be collapsed by applying pressure as described in US Patent Application Publication 20120107811 which is incorporated by reference (para. 152). The ‘811 document discloses wherein each blister is configured to be collapsed by a blister actuator comprising at least one blister actuator having a substantially flat profile (para. 5, 16) (Fig. 10, sheet 6 of 16). Each of the blisters disclosed by Agarwal et al. would equally be capable of being collapsed by at least one blister actuator having an outwardly extending curved profile, as the blisters are clearly configured to be collapsed by any application of pressure sufficient to collapse the material forming the blister, including pressure applied by a flat profile or an outwardly extending curved profile. Therefore, Agarwal et al. anticipates the noted limitation.
Regarding claim 22, Agarwal et al. discloses wherein the collapsible blisters are configured to eject the at least one reagent contained therein into a network of channels contained in the fluidic cartridge (para. 53, 66, 152) (Figs. 1-2, sheets 1-2 of 13).
Regarding claim 23, Agarwal et al. discloses wherein the collapsible blisters are adhered to a pneumatic foil (the blisters are adhered to foil 44, see para. 69; the foil reads on a pneumatic foil as it serves as an upper boundary to a region wherein material is moved by means of pressurized air, see para. 147 and Fig. 1, sheet 1 of 13).
Regarding claim 24, Agarwal et al. discloses wherein one of the collapsible blisters contains a reagent capable of performing cell lysis (para. 12-13, 74).
Regarding claim 25, Agarwal et al. discloses wherein one of the collapsible blisters contains a wash buffer (para. 12-13, 74).
Regarding claim 26, Agarwal et al. discloses wherein one of the collapsible blisters contains an elution buffer (para. 12-13, 74).
Regarding claim 27, as to the limitation of wherein the fluidic cartridge is configured to detect Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhea, Mycoplasma genitalium or methicillin resistant Staphylococcus aureus, this is a recitation of intended use of the claimed fluidic cartridge and has therefore been given appropriate patentable weight. Particularly, the target configured to be detected by the fluidic cartridge is determined by which probe(s) a user chooses to use with the fluidic cartridge, consistent with Applicant’s specification, and therefore the limitation does not introduce a structural difference over the prior art. Furthermore, Agarwal et al. discloses wherein the fluidic cartridge is configured to detect various bacterial diseases determining which probe(s) a user chooses to use with the device (para. 118, 138, 187). Therefore, the fluidic cartridge disclosed by Agarwal et al. would be fully capable of achieving the claimed intended use.
Regarding claim 28, Agarwal et al. discloses wherein the collapsible blisters are fluidly connected to an aperture (para. 106-107) (Figs. 1-2 and 8, sheets 1-2 and 8 of 13).
Regarding claim 29, Agarwal et al. discloses wherein each blister is configured to be collapsed by applying pressure as described in US Patent Application Publication 20120107811 which is incorporated by reference (para. 152) and the ‘811 document discloses wherein each blister is configured to be collapsed by a blister actuator comprising a foot (para. 5, 16) (Fig. 10, sheet 6 of 16); therefore, Agarwal et al. anticipates the claimed subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 11,318,468 in view of McDevitt et al. (US Patent Application Publication 2015/0004717) (already of record).
Regarding claim 21, claim 2 of the reference patent recites a fluidic cartridge for carrying out a diagnostic test on a sample contained therein, comprising at least one collapsible blister (encompasses more than one blister), each blister containing a liquid (reads on at least one reagent) and configured to be collapsed by application of pressure.
The claim does not expressly recite wherein each blister is configured to be collapsed by a blister actuator, at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile.
However, McDevitt et al. discloses that it was known in the art to provide a fluidic cartridge for carrying out a diagnostic test on a sample contained therein (Abstract, para. 34) comprising blisters (para. 15) configured to be collapsed by a blister actuator, including either of a blister actuator having a substantially flat profile or a blister actuator having an outwardly extending curved profile (para. 19).
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 blisters recited by the reference patent claim to be configured to be collapsed by a blister actuator, by at least one blister actuator having a substantially flat profile and by at least one blister actuator having an outwardly extending curved profile, based on the teachings of McDevitt et al., in order to arrive at a fluidic cartridge that can be readily actuated by conventional actuators known in the art.
Claim 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,413,620 in view of McDevitt et al. (US Patent Application Publication 2015/0004717) (already of record).
Regarding claim 21, claim 1 of the reference patent recites a fluidic cartridge for carrying out a diagnostic test on a sample contained therein, the cartridge comprising at least one collapsible blister (encompasses more than one collapsible blister) containing a reagent and configured to be collapsed by a blister actuator.
The claim does not expressly recite wherein each blister is configured to be collapsed by at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile.
However, McDevitt et al. discloses that it was known in the art to provide a fluidic cartridge for carrying out a diagnostic test on a sample contained therein (Abstract, para. 34) comprising blisters (para. 15) configured to be collapsed by either of a blister actuator having a substantially flat profile or a blister actuator having an outwardly extending curved profile (para. 19).
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 blisters recited by the reference patent claim to be configured to be collapsed by at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile, based on the teachings of McDevitt et al., in order to arrive at a fluidic cartridge that can be readily actuated by conventional actuators known in the art.
Claims 21 and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18481771 in view of McDevitt et al. (US Patent Application Publication 2015/0004717) (already of record).
Regarding claim 21, claim 1 of the reference application recites a fluidic cartridge for performing a diagnostic test on a sample, the cartridge comprising a lysis blister, a wash buffer blister, and an elution blister (reads on more than one blister each containing at least one reagent).
The claim does not expressly recite wherein each blister collapsible and is configured to be collapsed by a blister actuator, at least one blister actuator having a substantially flat profile and at least one blister actuator having an outwardly extending curved profile.
However, McDevitt et al. discloses that it was known in the art to provide a fluidic cartridge for carrying out a diagnostic test on a sample contained therein (Abstract, para. 34) comprising collapsible blisters (para. 15, 35) configured to be collapsed by a blister actuator, including either of a blister actuator having a substantially flat profile or a blister actuator having an outwardly extending curved profile (para. 19), such that reagents within the blisters can be dispensed through the cartridge (para. 35).
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 blisters recited by the reference patent claim to be collapsible and configured to be collapsed by a blister actuator, by at least one blister actuator having a substantially flat profile and by at least one blister actuator having an outwardly extending curved profile, based on the teachings of McDevitt et al., in order to arrive at a fluidic cartridge that can be readily actuated by conventional actuators known in the art to dispense reagents.
Regarding claim 24, claim 1 of the reference application recites a lysis blister (blister that contains a reagent capable of performing cell lysis).
Regarding claim 25, claim 1 of the reference application recites a wash buffer blister (blister that contains a wash buffer).
Regarding claim 26, claim 1 of the reference application recites an elution buffer blister (blister that contains an elution buffer).
This is a provisional nonstatutory double patenting rejection.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ismagilov et al. (US Patent Application Publication 2016/0263577) is directed to a diagnostic device comprising blisters for containing a lysis reagent, elution buffer, and wash buffer, respectively.
Conclusion
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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