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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/23/2024 was considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “140” has been used to designate both a microfluidic assembly and a reader device. 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.
Specification
The disclosure is objected to because of the following informalities:
Reference character “140” has been used to designate both a microfluidic assembly and a reader device. One of the reference characters should be switched to another reference character that is not already being used.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A fluid extraction system in claims 1 and 15 because it uses a generic placeholder (“system”) that is coupled with functional language (“fluid extraction”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The term is being interpreted to correspond to an optical piercing component comprising a light source or laser lancet, as described in ¶ [0028] of the published application; a mechanical piercing component comprising microneedles, micro blades, lancet, as described in ¶ [0029] of the published application; and equivalents thereof.
A reader device in claims 1 and 15 because it uses a generic placeholder (“device”) that is coupled with functional language (“reader” and “configured to detect one or more characteristics of the extracted fluid as a function of the sensor signal”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The term is being interpreted to correspond to a processor and memory, microcontroller, microprocessor, digital signal processor, and/or system on a chip, as described in ¶ [0054] of the published application, in combination with one or more elements of dedicated signal processing hardware and/or software modules, as described in ¶¶ [0056]-[0057] of the published specification, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 and 12 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 1 recites “An apparatus of a multipurpose fluid extraction device for diagnostics, the apparatus comprising” in lines 1-2. It is unclear what “An apparatus of a multipurpose fluid extraction device” means. An apparatus is understood to mean “a set of materials or equipment designed for a particular use” or “an instrument or appliance designed for a specific operation”. However, an apparatus of a device does not appear to correspond to either definitions, so it is unclear how the recitation should be interpreted. For the purposes of examination, the recitation will be interpreted to be “A diagnostic apparatus, the apparatus comprising”.
Claim 1 recites “a reader device” in lines 8-9 and 10. It is unclear how these recitations are related to each other. Are they the same or different reader device(s)? For the purposes of examination, the recitations will refer to the same reader device.
Claims 2-10 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “the assay component is removably inserted into the housing” in lines 1-2, which is a method step. However, claim 3 is directed to an apparatus. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). For the purposes of examination, the recitation will be interpreted to be “the assay component is configured to be removably inserted into the housing”. Claim 4 recites a similar limitation, so it is rejected on similar grounds.
Claim 12 recites “The method of claim 11, further comprising a housing” in line 1. Claim 12 is directed towards a method. However, the claim only provides limitations that are directed to the housing, and it does not describe how the housing is (A) used in the method or (B) related to the elements used in the method. Therefore, it is unclear how the housing is related to the method. For the purposes of examination, the recitation will be interpreted to be “The method of claim 11, wherein the multipurpose fluid extraction device comprises a housing”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6-7, 10-12, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) in view of US 2015/0024507 A1 (Han).
With regards to claims 1 and 11, Delamarche teaches an apparatus and method of use of a multipurpose fluid extraction device for diagnostics (Fig. 3 and ¶ [0006] disclose a method for monitoring bone implant health using a diagnostic apparatus; ¶ [0007] describes the diagnostic patch apparatus; also see ¶ [0101]), the apparatus comprising: a fluid extraction system, wherein the fluid extraction system is configured to extract a fluid from a user (Fig. 3 and ¶ [0057] depict one or more microneedles 314; ¶ [0058] discloses extraction of sample fluid through the microneedles); a microfluidic assembly, wherein the microfluidic assembly is configured to provide a flow of the extracted fluid (Fig. 3 depicts a sample pump 318; Fig. 5 and ¶ [0058] depict a sample pump 318 in the form of a multiple pumping microchannels 500 to enhance capillary action to suction fluid through an input microchannel 502), wherein the microfluidic assembly comprises a microfluidic channel (Fig. 5 and ¶ [0058] depict an input microchannel 502); a sensor, wherein the sensor is configured to output a sensor signal to a reader device (Figs. 3 and 6 and ¶ [0066] depict at least one sensor 340, each sensor 340 having a corresponding electrical lead 341 for connection with the reader module; ¶ [0068] depict sensors 340 sensing one or more of various analytes; Figs. 3 and 8 and ¶ [0069] depict the reader module 306 having one or more sensor interfaces 368 to connect to the electrical leads 341 and to read the sensor outputs); a reader device, wherein the reader device is configured to detect one or more characteristics of the extracted fluid as a function of the sensor signal (¶ [0056] depicts the reader module 306 obtains measurements from the analysis module 304 (which includes the sensors 340) and facilitates processing of the measurements to assess a patient’s diagnostic status; ¶ [0076] discloses that based on the sensor readings, the reader module 306 determines possible presence of synovial cavity infection using microprocessor 376); an assay component fluidically connected to the microfluidic assembly, wherein the assay component is configured to test the extracted fluid (Figs. 3 and 6 and ¶ [0066] depict at least another sensor 340 in fluid communication with sample chamber 322 via fluid conduit 342; ¶ [0058] depict sample chamber 322 in fluid communication with sample pump 318; ¶ [0075] discloses that the sensor suite may include two or more electrodes for electrochemical detection of analytes, e.g., electrochemical immunoassay); and a fluid collecting reservoir fluidically connected to the microfluidic assembly, wherein the fluid collecting reservoir is configured to collect the extracted fluid from the microfluidic assembly (Fig. 3 and ¶ [0063] depict a sponge or overflow volume 332 in fluidic communication with the sample chamber 322; ¶ [0058] depict sample chamber 322 in fluid communication with sample pump 318).
Delamarche is silent regarding whether the sensor is a photonic sensor.
In the same field of endeavor of monitoring blood samples (¶ [0003] of Han), Han teaches a photonic sensor for monitoring biomarkers (¶ [0044] depict an immunodiagnostic sensor/detector including at least one optical microring resonator). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one of the sensors of Delamarche with the photonic sensor of Han. Because both elements are capable of detecting biomarkers in a blood sample (¶ [0008] of Han; ¶ [0068] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claims 2 and 12, the above combination teaches or suggests a housing, wherein the housing is portable (¶ [0056] and Fig. 3 of Delamarche depict the device being a patch, which is portable; ¶ [0062] of Delamarche depict various chambers of the sampling module being defined by walls 331, which indicate that the patch includes a housing).
With regards to claims 6 and 16, the above combination teaches that the microfluidic assembly is further configured to provide the flow of the extracted fluid to the photonic sensor (see the above combination regarding Delamarche in view of Han; see ¶ [0066] of Delamarche which indicates that microchannel 348 connects the sample subchamber 346 to sensor 340).
The above combination is silent regarding whether the flow of the extracted fluid is over the photonic sensor.
In the same field of endeavor of monitoring blood samples (¶ [0003] of Han), Han teaches a flow of fluid over the photonic sensor (Fig. 1A and ¶ [0043] depict surfaces of optical resonators receive flowable medium over them). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the microfluidic assembly of the above combination to incorporate that it is configured to provide the flow of the extracted fluid over the photonic sensor as taught by Han. The motivation would have been to provide an optimal configuration of fluid flow for analyzing the fluid using the photonic sensor.
With regards to claims 7 and 17, the above combination teaches or suggests that the photonic sensor comprises a microring resonator (¶ [0044] of Han depict an immunodiagnostic sensor/detector including at least one optical microring resonator).
With regards to claims 10 and 20, the above combination teaches or suggests the fluid collecting reservoir is further configured to passively pump the extracted fluid for the flow of the extracted fluid of the microfluidic assembly (¶ [0063] of Delamarche teaches a sponge or overflow volume 332 comprising a microchannel for allowing the fluid to continue to flow through the sample chamber 322).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) in view of US 2015/0024507 A1 (Han), as applied to respective claims 2 and 12 above, and further in view of US 2011/0172508 A1 (Chickering, III).
With regards to claims 3 and 13, the above combination is silent regarding whether the assay component is removably inserted into the housing through a first aperture of the housing.
In the same field of endeavor of sampling and diagnostic devices, Chickering, III teaches an assay component is removably inserted into a housing through a first aperture of the housing (¶ [0130] discloses a user may need to insert a test strip in a device (and optionally, withdraw and replace the test strip between uses), wherein the insertion necessarily requires insertion through an aperture or opening). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patch of the above combination to incorporate an assay component is removably inserted into a housing through a first aperture of the housing as taught by Chickering, III. The motivation would have been to allow for the assay component to be replaced between uses (¶ [0130] of Chickering, III) and/or to allow the test strip to be removed from the device and determined externally (¶ [0130] of Chickering, III).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) in view of US 2015/0024507 A1 (Han), as applied to respective claims 2 and 12 above, and further in view of US 2021/0069714 A1 (Jebrail)
With regards to claims 4 and 14, the above combination is silent regarding whether the fluid collecting reservoir is removably inserted into the housing through a second aperture of the housing.
In the same field of endeavor of testing fluid samples, Jebrail teaches a fluid collecting reservoir is removably inserted into the housing through an aperture of the housing (¶ [0266] depicts a wick can be removable and replaceable from the device, such as through a port or opening). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the sponge 332 of Delamarche of the above combination is removably inserted into the housing through an aperture of the housing as taught by Jebrail. The motivation would have been to allow for the sponge to be replaced when it is saturated.
The Examiner notes that Delamarche teaches an opening 312 (a first aperture) in Fig. 3 The above combination in view of Jebrail results in a second aperture for removing sponge 332.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) in view of US 2015/0024507 A1 (Han), as applied to respective claims 1 and 11 above, and further in view of US 2009/0318834 A1 (Fujiwara).
With regards to claims 5 and 15, the above combination is silent regarding whether the fluid extraction system comprises an optical skin piercing component configured to pierce a skin of the user.
In a system relevant to the problem of collecting fluid samples, Fujiwara teaches a fluid extraction system comprises an optical skin piercing component configured to pierce a skin of the user (¶ [0115] depicts a blood test apparatus using a laser emitting apparatus that can perform puncturing). Fujiwara further teaches a channels for collecting the fluid from the user (Figs. 9-10 and ¶ [0127] depicts blood spreading inside storing part). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle and fluid collection scheme of Delamarche of the above combination with the optical skin piercing component and fluid collection scheme of Fujiwara. Because both elements are capable of piercing skin and collecting a fluid sample (¶¶ [0125], [0127] of Fujiwara; Fig. 3 and ¶¶ [0057], [0058] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0103884 A1 (Delamarche) in view of US 2015/0024507 A1 (Han), as applied to respective claims 1 and 11 above, and further in view of US 2021/0318300 A1 (Miller)
With regards to claims 8 and 18, the above combination is silent with regards to whether the assay component comprises a lateral flow assay.
In a system relevant to the problem of detecting analytes in a fluid sample, Miller teaches an assay component comprising a lateral flow assay (¶ [0114] teaches a lateral flow assay for testing a fluid sample). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the assay component of Delamarche to incorporate that it is a lateral flow assay. Because both elements are capable of detecting components in a sample (¶ [0114] of Miller; ¶ [0075] of Delamarche), it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claims 9 and 19, the above combination is silent with regards to whether the photonic sensor is further configured to detect a change in the lateral flow assay of the assay component.
In a system relevant to the problem of detecting analytes in a fluid sample, Miller teaches a photonic sensor is further configured to detect a change in the lateral flow assay of the assay component (¶ [0114] discloses using ring resonators to detect the result of a lateral flow assay). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate that the photonic sensor is further configured to detect a change in the lateral flow assay of the assay component as taught by Miller. The motivation would have been to reduce sample volume, simplify operation, deliver a simple readout, or improve re-usability (see ¶ [0012] of Miller).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791