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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/14/2025 has been entered.
Status of Claims
Claims 22-68 are pending. Claim 22-30 and 43-68 remain withdrawn as drawn to non-elected inventions. Claim 31 has been amended. Claims 31-42 have been examined.
Response to Arguments
Applicant’s arguments filed 10/14/2025 have been fully considered but are not found to be persuasive.
Applicant argues that Terbrueggen provides a bar coded reference sheet that includes bar coded protocols but that there is no identifier at all on the fluidic device, as present in the amended limitation, and further points to Figures 11 and 12 of Terbrueggen that shows a scenario of how the bar codes are used. This argument is not persuasive because the reference explicitly states at paragraph 0428: “the device (or alternatively, each station) comprises a barcode reader to read a corresponding barcode on the cartridge. These barcodes may be used for a wide variety of purposes, including, but not limited to, identifying the sample (e.g. patient number or code), the test being done, the batch number of the chip, calibration information, assay protocols including cycle time, signal processing requirements, etc.”. While other paragraphs in the reference and the Figures disclose alternative uses for the barcodes and a barcoded reference sheet, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure of non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed ...." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). (see MPEP § 2123).
Examiner would also like to note that the instant claims are drawn to a system and thus patentable weight is given to the structure of the system. As currently recited, the claims are drawn to a system comprising a fluidic device comprising an identifier, a computer, a mechanism, actuating elements, a detection assembly and a communication assembly. While Terbrueggen states that the bar code/bar code reader store a protocol, the claimed functional limitations are also drawn to intended use. Examiner suggests providing structural limitations (structural properties of the identifier, explicit protocols configurations relative to other structural components of the system, physical components, spatial relationships between components, dimensions, materials, etc.) to any of the structural components of the claim (fluidic device, identifier computer, mechanism, actuating elements, detection assembly and/or communication assembly) that would structurally distinguish from the system of Terbrueggen since essentially, the teachings of the reference only need to be capable of reciting the intended use of the claims.
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 31-42 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 31 at line 5 recites “transmission of the protocol” and there is no antecedent basis for “the protocol” and thus it is unclear what protocol is being referenced.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 31-40 and 42 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Terbrueggen et al. (US 2004/0053290, Pub Date: 03/18/2004, hereinafter “Terbrueggen”).
Regarding claim 31, Terbrueggen teaches throughout the publication a system for detecting a biological analyte (paragraph 0060), comprising:
a fluidic device configured to perform an assay to yield a signal indicative of the presence or concentration of a biological analyte in a sample (paragraph 0060, biochips for analysis and detection of target analytes in samples), the fluidic device comprising an identifier to provide the identity of the fluidic device that is adapted to trigger the transmission of the protocol (paragraph 0428, barcode on the cartridge);
a computer storing a protocol, the protocol being associated with an identity of the fluidic device, and the protocol being for controlling fluid movement caused by actuating elements interacting with the fluidic device to perform the assay (paragraphs 0428-0430, barcode reader to read the barcode including assay protocols, barcodes can include information for starting the assay which would inherently include fluid movement for the assay to be conducted);
a mechanism configured to receive the fluidic device (paragraph 0013, cartridge holders holding the cartridge);
actuating elements (paragraph 0092, active microvalve) configured for interaction with the fluidic device in accordance with the protocol (paragraphs 0091-0108);
a detection assembly configured for detecting the signal (paragraph 0285); and
a communication assembly configured for receiving the protocol from the computer (paragraph 0451-0453).
Regarding claim 32, Terbrueggen teaches the system wherein the actuating elements are further configured to pump or valve fluid in accordance with the protocol (paragraphs 0092-0102).
Regarding claim 33, Terbrueggen teaches the system wherein the actuating elements comprise a pump or a valve, the actuating elements configured to move fluid through the fluidic device (paragraphs 0092-0102).
Regarding claim 34, Terbrueggen teaches the system wherein the fluidic device does not include a pump (paragraphs 0092-0093, pump is not required as seen by the presence of various valves to move the fluid).
Regarding claim 35, Terbrueggen teaches the system wherein the fluidic device comprises multiple reaction sites, and is configured to perform a first assay using a first reaction site, and to perform a second assay using a second reaction site (paragraphs 0060 and 0154-0155).
Regarding claim 36, Terbrueggen teaches the system wherein the first and second assays are configured to detect the presence or concentration of at least two different biological analytes in the sample (paragraphs 0071, 0155 and 0166).
Regarding claim 37, Terbrueggen teaches the system wherein the fluidic device comprises a burstable seal (paragraph 0087, seal on inlet port), a reagent chamber (paragraphs 0149-0150), and a fluidic channel (paragraph 0011, microchannel 110), wherein the actuating elements are controllable to cause the burstable seal to burst to move reagent from the reagent chamber into the fluidic channel for fluid communication with a reaction site to perform the assay (paragraph 0087).
Regarding claim 38, Terbrueggen teaches the system wherein the fluidic device comprises an outer layer comprising elastomeric, flexible, silicone or moisture-impermeable material (paragraph 0079).
Regarding claim 39, Terbrueggen teaches the system wherein the computer comprises at least one of: a computer system, a server, or an electronic device capable of storing information or processing information (paragraph 0442 and 0445-0446).
Regarding claim 40, Terbrueggen teaches the system wherein the protocol comprises instructions to a controller to control the actuating elements to perform the assay (paragraphs 0428-0429).
Regarding claim 42, Terbrueggen teaches the system wherein the fluidic device comprises an assay assembly for the sample to react with reactants contained within the assay assembly for performing the assay (paragraph 0060), wherein the actuating elements are controllable to move fluid through the fluidic device (paragraphs 0091-0102).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Terbrueggen et al. (US 2004/0053290, Pub Date: 03/18/2004, hereinafter “Terbrueggen”) as applied to claim 31 above, and further in view of Glezer et al. (US 2004/0189311, IDS).
Regarding claim 41, Terbrueggen teaches throughout the publication devices to receive and analyze biochips for detection of target analytes (paragraph 0060). More specifically, Terbrueggen teaches that the samples that can be used within the biochips can include bodily fluids including, but not limited to, blood, urine, serum, lymph, saliva, anal and vaginal secretions, perspiration and semen (paragraph 0062).
While Terbrueggen does not specifically teach that one of the bodily fluids can be plasma, Glezer teaches an analyte detection system that can incorporate sample types such as whole blood, plasma, mucous, etc. (paragraph 0101).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the system of Terbrueggen, a plasma sample as taught by Glezer because Terbrueggen is generic regarding the types of samples that can be included on the biochips for analysis and one skilled in the art would have been motivated to choose the appropriate sample based on the desired analytes being detected.
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 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,908,093. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 31, Patent 093 recites a method comprising:
inserting a cartridge into a reader assembly, the reader assembly comprising a processor, an analyte signal detector, and a communication interface, the cartridge being configured to be coupled to the reader assembly, the cartridge comprising:
i) a structure configured to receive a sample;
ii) a reactant capable of reacting with a biological analyte in the sample; and
iii) an information storage unit storing identifier information identifying the cartridge;
obtaining the identifier information from the information storage unit;
transmitting the identifier information to a computer server, prior to performing an assay using the cartridge coupled to the reader assembly;
in response to receiving the identifier information, the computer server using the received identifier information to select a protocol from a plurality of protocols stored in the computer server, the selected protocol then being transmitted electronically by the computer server to the communication interface of the reader assembly, wherein the selected protocol comprises instructions to the processor to perform the assay using the cartridge;
measuring with the analyte signal detector, in accordance with the selected protocol, a first signal produced by a first assay of the sample, wherein the sample comprises a known quantity of the biological analyte;
measuring a second signal produced by a second assay of the sample after spiking the sample with a known quantity of the biological analyte;
plotting the difference between said first and second signals against an expected signal representing a target value, wherein the target value is a value expected for the known quantity of the biological analyte;
computing a best fit of calibration parameters by minimizing the sum of the square of the differences between the target value and calculated analyte values from the first and second signals; and
updating a factory calibration parameter of the reader assembly (reference claim 1).
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6 and 23 of U.S. Patent No. 8,841,076. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 31, Patent 076 recites a method comprising:
a) providing a cartridge comprising at least one sample collection unit and an assay assembly comprising a plurality of reaction sites each having a reactant contained therein;
b) reacting a first sample of biological fluid of less than about 50 ul from a subject with the reactants contained within the reaction sites of said assay assembly, wherein said assay assembly yields detectable signals generated from a plurality of analytes in the first sample that are indicative of concentrations of the plurality of analytes;
c) detecting said detectable signals with a reader assembly;
d) comparing said concentrations of said plurality of analytes with stored pharmacological data according to a bioinformatics model at an external device;
e) repeating over the course of a preclinical study the reaction and detection steps with at least a second sample of biological fluid from the same subject collected at a different time from the first sample; and
wherein said reacting step (b) occurs in accordance with a protocol transmitted from said external device that is external to the reader; and
wherein said protocol is selected by determining a plurality of protocols associated with the cartridge, and based on information about the subject, selecting one of said plurality of protocols associated with the cartridge to be run to detect said analytes (reference claim 1/2), wherein said cartridge interfaces with the reader assembly comprising a detection assembly for detecting said detectable signals, and a communication assembly for transmitting said detected signals to said external device (reference claim 3), wherein said protocol varies depending on the identity of said cartridge that is recognizable by an identifier detector (reference claim 6), and detecting an identifier on said cartridge; transmitting said identifier to the external device; and selecting the protocol to be run on said cartridge from the plurality of protocols on said external device associated with said identifier (reference claim 23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677