DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 25, 2025 has been entered.
Claims 1-20 remain pending. Applicant amended independent claims 1 and 14.
Response to Arguments
The amendment necessitated the new grounds of rejection set forth below. Nevertheless, some of Applicant’s arguments directed to the patentability of the claims remain pertinent. That said, the arguments have been fully considered but they are not persuasive.
Applicant argues that the outstanding rejection should be withdrawn because chamber 119 taught by Petersen et al. (“Petersen”) cannot anticipate the claimed “mixing chamber” (Remarks 6). According to Applicant, Petersen identifies chamber 119 as a “lysing chamber” (Remarks 6), and hence Petersen “prevents interpreting chamber 199 as a mixing chamber” (Remarks 7).
The argument is not persuasive. Contrary to the implication of Applicant’s remarks, the claims read on the prior art, not the other way around. Consequently, nomenclature used by the prior art does not determine how claims are interpreted. Rather, claim limitations determine how a claim should be interpreted. In this case, notwithstanding the nomenclature used by Petersen, the limitations directed to the claimed “mixing chamber” read on chamber 119 taught by Petersen. For the foregoing reason, Applicant’s argument that the claims are patentable over the disclosure of Petersen because Petersen fails to teach the limitation, “the mixing chamber comprising a lysing assembly” is not persuasive.
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.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 1, 1, 4, 6, 8, 1, 9-12, 19-23, 26 and 27 of US 11,287,421 B2 in view of Dority et al. (“Dority”) (US 2003/0162304 A1), respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of the claims of US 11,287,421 B2 and the disclosure of Dority anticipate or render obvious all of the limitations recited in the respective claims of the instant application.
The claims of US 11,287,421 B2 recite all of the limitations of corresponding claims of the instant application, except:
reciting that the reactants are bound to the reaction sites; and
reciting that the lysing assembly contains a porous material having a disc shape with a diameter greater than its thickness.
However, it would have been obvious to one of ordinary skill in the art to incorporate the missing subject matter into the claims of US 11,287,421 B2.
Specifically, it would have been obvious to immobilize the reactants to the reaction sites to facilitate analysis. Immobilizing reactants to a surface of a reaction site (e.g. a solid phase) is well-known in the art and considered a conventional way of reacting a sample with reactants.
It also would have been obvious to incorporate lysing agents in the mixing chamber using any conventional method, for example by impregnating a circular, porous lysis paper 30 with the lysing agents, as taught by Dority (see [0044] and Fig. 4). Naturally, a circular paper is in the shape of a disc having a diameter greater than its thickness (see also Fig. 4 of Dority).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6, and 8-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Petersen (US 2002/00421125 A1) in view of Nakamura et al. (“Nakamura”) (US 2004/0072156 A1) and Dority.
With respect to claim 1, Petersen discloses a system configured to detect an optical signal indicating the presence of an analyte in a bodily fluid sample, the system comprising:
-a cartridge 101 configured to perform an assay (see Fig. 2), the cartridge 101 comprising:
-a sample collection unit 103 capable of receiving the bodily fluid sample;
-a metering channel 105 configured to meter a volume of the sample;
-a mixing chamber 119 configured to be brought into fluidic communication with the metering channel 105 and to receive a portion of the sample, the mixing chamber further comprising a lysing assembly (see [0048]);
-a reagent chamber 141 including a dried reagent (see [0075]), the reagent chamber 141 being configured to be brought into fluid communication with the mixing chamber 119 (see Fig. 2); and
-a plurality of reaction sites (space inside reaction chamber 143) in fluid communication with the reagent chamber 141, wherein the reactions sites are configured to generate an optical signal upon reacting with the analyte present in the bodily fluid sample (see [0075] and [0117]).
The system taught by Petersen differs from the claimed invention in that Petersen does not disclose that the reaction sites comprise reactants bound thereto. In addition, Petersen does not disclose that the lysing assembly comprises a porous disc comprising a diameter greater than its thickness.
Regarding reactions sites comprising bound reactants, Nakamura discloses a method of detecting amplified PCR products, wherein the method comprises a step of immobilizing the PCR products to a solid-phase and optically detecting the immobilized PCR products using fluorescence (see [0742]). In light of the disclosure of Nakamura and given that the disclosure of Petersen is vague regarding how the amplified analyte in chamber 143 is detected, it would have been obvious to one of ordinary skill in the art to provide the reaction sites in chamber 143 with immobilized reactants that can bind the amplified analyte. The modification would enable immobilization of the amplified analyte, thus facilitating detection of the amplified analyte.
Regarding the porous disc, Dority teaches a device for processing biological samples (e.g. cells) (see [0007] and Fig. 4), the device comprising a zone for performing cell lysis (see [0044]). The zone comprises a disc-shaped lysis paper 30 impregnated with a lysing agent (see [0044] and Fig. 4). In light of the disclosure of Dority, instead of using a storage chamber 109 for storing liquid lysing reagents (see [0055]), it would have been obvious to one of ordinary skill in the art to incorporate dry lysing reagents in the mixing chamber 119 by providing a disc-shaped paper impregnated with lysing reagents. By using dry reagents, the modification would increase the shelf life of the cartridge.
With respect to claim 2, because the signals are optical, they are detectable by a CCD.
With respect to claim 3, the reactants are configured to generate fluorescent signals (see [0117]).
With respect to claim 4, the cartridge further comprises a fluidic channel 121/135 connecting the mixing chamber 119 and the reagent chamber 141 (see Fig. 2)
With respect to claim 6, the cartridge further comprises a fluidic channel connecting the reagent chamber 141 with the plurality of reaction sites 143 (see Fig. 2).
With respect to claim 8, the cartridge further comprises a dilution chamber 127 configured to receive a diluent and being configured to be brought into and out of (via valves 123) fluidic communication with the metering channel 105 (see Fig. 2).
With respect to claim 9, the lysing assembly is configured to lyse cells present in the bodily fluid sample (see [0048]).
With respect to claim 10, the mixing chamber 119 is configured to receive any fluid introduced thereto, including a diluent from a dilution chamber and the biological fluid sample (see Fig. 2).
With respect to claims 11 and 12, the mixing chamber 119 comprises a movable mixing element (e.g. beads) configured to cause the mixing of the portion of the biological fluid sample with the diluent (see [0017]).
With respect to claim 13, Petersen discloses that the cartridge may comprise magnetic beads whose movements can be controlled by a magnet (see [0119]). Given that the mixing chamber 119 comprises beads intended to be moved around inside the mixing chamber (see [0017]), it would have been obvious to one of ordinary skill in the art to make the beads responsive to a magnet.
Claims 5 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Petersen in view of Nakamura and Dority as applied to claims 1-4, 6 and 8-13, and further in view of Silver et al. (“Silver”) (US 6,197,254 B1).
With respect to claims 5 and 7, none of Petersen, Nakamura and Dority disclose a burstable seal situated in the channels leading into and out of the reagent chamber 141. However, given that the reagent chamber 141 comprises dried reagents (see [0075]), it would have been obvious to one of ordinary skill in the art to seal the chamber (at both ends) to preserve the reagents, as taught by Silver (see lines 43-50, col. 9). Moreover, it would have been obvious to make the seals frangible as taught by Silver (see line 46, col. 9) so that fluid communication with the reagent chamber 141 can be established when the cartridge is used.
Claims 14-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Petersen in view of Nakamura, Dority and Boecker (US 2003/0073931 A1).
With respect to claim 14, the combination of Petersen, Nakamura and Dority teaches a system configured to detect an optical signal indicating the presence of an analyte in a bodily fluid sample, as discussed above. In addition, the system further comprises a reader assembly 211 configured to receive the cartridge and configured to detect the optical signals (see [0116]-[0117]).
The system differs from the claimed invention in that none of Petersen, Nakamura and Dority disclose a communication assembly for transmitting data to an external device. Nevertheless, it would have been obvious to one of ordinary skill in the art to provide the system with a communication assembly as taught by Boecker (see abstract) so that the assay results can be transmitted to an external source (e.g. a doctor’s office).
With respect to claim 15, Petersen discloses that the cartridge is configured to* run a specific assay based on an assay protocol transmitted to the reader assembly (see [0059]). While Petersen does not recite the provision of multiple reactants in the reaction sites, it would have been obvious to one of ordinary skill in the art to configure the Petersen system to detect the presence of more than one analyte so that a single sample (e.g. blood) can be used to conduct multiple tests. In fact, Nakamura discloses a method of using a single sample (e.g. blood, saliva, see [0013]) to assay for the presence of multiple analytes (polymorphisms) (see claims 1 and 5). If the Petersen system is further modified as suggested, then the plurality of reaction sites in chamber 143 would comprise different reactants.
*As discussed above, the limitation “the cartridge is configured to…from the external device” further limits a configuration of the cartridge and the cartridge only. Consequently, the means by which the reader assembly receives the assay protocol does not further limit the configuration of the cartridge. As long as the cartridge runs a specific assay, the claimed configuration is anticipated.
With respect to claim 16, as discussed above, it would have been obvious to one of ordinary skill in the art to provide the system with a communication assembly. That said, it would have been obvious to provide the system with any conventional communication assembly (e.g. wireless connection, wired connection). If the system is provided with a wired communication assembly, then any assay protocol transmitted to the reader assembly would be transmitted via the wired connection.
With respect to claims 17 and 18, the cartridge further comprises an identifier readable by the reader assembly and configured to provide the identity of the cartridge (see [0061]), wherein the identifier also identifies the assay protocol (see [0059]).
With respect to claim 19, based on the intended use of the system (see [0047] of Petersen disclosing detection of amplified nucleic acid sequences), the system appears to be configured to monitor more than one pharmacological parameter, as evidenced by Nakamura (see [0004]-[0006] of Nakamura disclosing that analysis of amplified DNA sequences can be used to determine compatibility with various drugs). Based on the broadest reasonable interpretation of claim 19, the disclosure of Petersen is deemed to anticipate the claim.
With respect to claim 20, while Petersen discloses optical detectors, including diodes (see [0117]), Petersen does not disclose a detector in the form of a charge coupled device (CCD). However, CCD is a conventional form of detector used to detect assays (see [0039] of Nakamura). That said, it would have been obvious to one of ordinary skill in the art to provide the reader assembly taught by Petersen with a CCD.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796