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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 30, 2025 has been entered.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive.
It is noted that applicant states:
The Examiner contends there is no structure claimed as being capable of providing for any movement of the first and second apparatuses, or for providing for rotation. Applicant respectfully submits that amended claim 1 requires a point of the housing of the first apparatus that the second apparatus is configured to rotate about. Said point is structure capable of providing for rotational movement.
The Examiner contends that the second portion is minimally structurally only one well. Applicant respectfully submits that the second apparatus is at least two wells in claims 2-3.
The examiner disagrees. There is no “point” of the housing described in the specification as being any specific structure of the housing. Nor is such point claimed as being any specific structure (mechanical structure, motor, etc.) that provides rotational movement of the second apparatus (only defined as a single well in claim 1). Such point is a location, a single fixed point. For example, paragraph [0031] of the publication states: “in some embodiments, the second portion can move around a fixed point with respect to the first portion (for example in a plane defined by the x and y dimensions). The embodiment depicted in FIGS. 4A and 4B could have such movement, with the second portion 420 moving in a circular direction (as indicated by the arc designated m.sub.a) around a fixed point with respect to the first portion 410.” Therefore, such point is a location, a single fixed point of reference and is not any specific structure that can provide movement as stated by applicant. If applicant disagrees, it is hereby requested that applicant provide for where a point is disclosed as being a specific structure that provides for rotational movement. Furthermore, the phrase “one more wells” only requires one well. Therefore, in claim 1, the second apparatus is only required to be defined as one well.
The claims have not been amended to remedy all 112 issues. See rejections herein.
Applicant’s arguments, see remarks/amendment, filed October 30, 2025, with respect to the 102 and 103 rejection(s) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Reed et al., US 20050232820 A1.
Terminal Disclaimer
The terminal disclaimer filed on May 19, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,933,793 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that claims 1-13 and 18-20 are directed to an apparatus. Although the claims mention, a target analyte (not specified), sample (not specified, required to be any specific material nor state of matter), fluid (liquid or gas), signal (not defined, not required to be structure), and binding sites (not structurally defined), none of the prior are positively claimed as structural elements nor specifically structurally defined in the claims. All of the prior are considered as materials/articles intended, can possibly be worked upon/used with by the apparatus (device).
It is noted that the “for detecting…” clause of the preamble is directed to intended use “for…” and the respective “configured to…” clauses recited throughout the claims do not provide for any further structural elements of the device, but are directed to intended, possible use. Employing the phrase “configured to…” before recitations of possible intended uses of an element/apparatus does not provide for additional structure of the element/apparatus. The claims are directed to an apparatus not a process of use, there is no requirement for the apparatus of claim 1 to be used in any method at all, to perform any method steps and/or be used as may be intended by applicant. There is no requirement for any fluid/sample to be present nor be drawn, delivered, and/or flow from anywhere/anything to anywhere/anything.
It is noted that the fluid introducer is not required to be in fluidic communication with the pathway. The configured to clause is directed to what is possible. Furthermore, the fluid introducer is not is not capable providing for any motive force to any fluid. No fluid actuator (pump) has been positively claimed to provide for the ability to transport fluid.
It is noted that there is no structure claimed as being capable for providing for any rotational movement of the first and second apparatuses, the rotational movement can be performed manually by hand or any other suitable means. It is noted that where, how, when, etc. one chooses to “move” the apparatuses is a matter of choice. The same is applicable to the housing in claim 12. There is no structure positively claimed that can provide for any movement of the housing.
It is noted that the term “apparatus” is relatively broad. However, each apparatus is only defined by the positively recited structures in the claim.
It is noted that “a housing” can be considered as anything in which “a pathway” (not defined and being any specific structure(s)) exists within. The first “first apparatus” is a housing and a structurally undefined “fluid introducer” that are not required to be structurally connected to each other.
It is noted that the phrase “one or more wells” only requires one well. Therefore, the second apparatus is minimally structurally only one well in claim 1.
As to claim 12, it is noted that there is no structure claimed that can provide for any movement of the housing. There is nothing precluding one for moving rotating the first and second apparatuses by hand.
As to claim 4, the fluid introducer is only defined as a pipette tip.
As to claims 15-16, it is noted that the steps of the claims are not required to be performed any specific order relative to the steps of claim 14. The “to permit” clause of claim 15 recites the intended purpose of the moving, but does not required any obtaining to be performed during nor after such moving.
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 6, 8, 10-11, 13, and 19 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.
As to claim 6, it is unclear if the first and second ports are intended to be elements of the pathway or some other structure because the claim does not clearly recite such.
As to claim 8, it is unclear how the device can comprise a resonator surface without claiming a resonator.
The term “teardrop shaped” in claim 11 is a relative term which renders the claim indefinite. The term “teardrop shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Teardrop shaped is not a known geometrical shape. Tears/teardrops can have various different shapes. What may be considered as teardrop shaped to one person may not be considered as such to another and vice versa. Furthermore, it is noted that a well is a 3+ dimensional structure. Therefore, it is unclear if the claim is intended to refer to an overall shape of a well or a specific cross-sectional shape of a well because the claim does not provide for such.
The term “substantially round” in claim 13 is a relative term which renders the claim indefinite. The term “substantially round” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication as to what variations from “round” that the phrase encompasses. Furthermore, the examiner fails to locate the term in the specification. It is unclear if applicant intending for the second apparatus to round as in a sphere or if applicant intends for the second apparatus to have a specific cross-sectional shape that is circular. The examiner presumes the latter which appears to be consistent with the specification and drawings.
As to claim 19, it is unclear if it is intended for the system to comprise an electrical connection board and such board to be connected to the sensor and any other structures because the claim does not clearly recite such. It is noted that the reciting at least one offset is positioned between an electrical connection board and sensor does not require the board to be an element of the invention. Furthermore, if applicant intends for the pathway to comprise a slot, then the claim should clearly recite such.
The term “proximate” in claims 10 and 19 is a relative term which renders the claim indefinite. The term “proximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In claim 19, it is unclear what the phrase “and positioned proximate a slot” modifies because the claim does not clearly recite such. Furthermore, the term proximate does not provide for any definitive structural relationship (location nor structural connection) between any positively claimed structural elements. In claim 10, it is unclear what is the structural nexus, relative location of the waste wick and pathway. The phrase does not provide for any definitive distance nor definitive relative location. What may be considered as “proximate” to one person may not be considered as such to another and vice versa. Any structures can be subjectively considered as proximate to each other. All of the claimed elements are proximate to each other and further structures that are not claimed as elements of the invention.
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.
Claim(s) 1-5, 7, 11-15, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada et al., US 2003/0027225 (and alternatively Kersco et al, US 6,132,685) in view of Reed et al., US 20050232820 A1.
Wada discloses systems, devices and methods for performing fast and efficient separation and collection of components of a sample.
The microfluidic systems of the present invention include microfluidic devices integrated with control and transport modules as well as detection systems (sensor having at least one surface) for detection of the end results of a reaction or analysis performed within the microfluidic device. The controlling and transport modules may optionally include robotic components for moving system modules relative to one another. Optionally, the robotic components may be used for positioning the microfluidic device relative to a receptacle, e.g., a well on a microtiter plate, a petri dish, an inlet port for an analytical instrument such as a mass spectrophotometer, Gas Chromatograph or the like. The microfluidic systems of the invention also include computer and software for controlling the various systems components. (paragraph 0023).
A schematic illustration of a simplified microfluidic device of the present invention is shown in FIG. 1. As shown in panel A the microfluidic device 100 (first apparatus/housing) includes a planar body structure 102, having disposed therein a main channel 104. The main channel is in fluid communication with wells 106, 108, 110, 114 and 116 via side channels 120, 122, 124, 126, and 128 respectively (pathways including inlets/outlets). The device illustrated also includes a capillary element 118 that is attached to the finished structure. (paragraph 0025-26).
In these devices, a sample mixture is introduced into the reaction channel by adding the reaction mixture into one of the reservoirs/wells that are in fluid communication with the reaction channel. As alluded to above, optionally a second fluidic interface such as a capillary (introducer) element may be integrated with the body structure of the device to allow for accession to sample material that may be external to the body structure, e.g., a well in a multiwell plate (second apparatus), which is placed into fluid communication with the fluidic interface which is itself in fluid communication with the reaction channel. (paragraph 0027).
Further the systems also include instrument controllers such as electrically controlled robotic modules that motorize the movement of the microfluidic device and/or the external plate assembly to allow the proper dispension of isolated materials, components or particles from a mixture. (paragraph 0036)
Robotic interfaces are described in detail in U.S. Pat. No. 6,132,685, which is herein incorporated by reference in its entirety for all purposes. (paragraph 0037).
As shown in Figure 3, the microfluidic device (first apparatus) is linked to the second apparatus 310 (comprising wells) via various components. (paragraphs 0040-41). Furthermore, the components are linked to each other via transport systems as described in detail in U.S. Pat. No. 6,132,685 (see for example figures 2-5) and the wells can be sealed via foil.
Wada does not disclose that the second apparatus is configured to be rotated about a point of the housing.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Various moving devices such as circular/round platforms, turntables, carousels, discs, etc. were conventionally known in the art for moving various structures including wells relative to dispensing structures. For example, Reed discloses a system comprising a rotatable table 872 on which microplates 20 (including wells) are rotated about a point of a dispensing device 814 (housing) to allow fluids to be transferred between the dispensing device and wells of the microplates. (Figures 66-67; paragraphs 0298, 319).
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art to modify the system of Wade to include a rotatable table to provide for the relative positioning of wells to a dispensing device to allow for fluid to be transferred to wells as taught by Reed as such would provide for predictable results.
As to claim 5, Wada discloses various sensors/detectors may be employed in the system. (paragraphs 0023, 32, 34, 38). Including a detector 304 at a channel/pathway. (paragraph 0041).
As to claims 7 and 11 Wada discloses the use of various fluidic actuators including pumps that can provide for fluid movement in a first and second direction. (paragraphs 0024, 35, 40).
The invention includes a computer coupled to the detector/sensor and software. (paragraphs 0023, 41).
As to claims 12-13, the microfluidic device and well plate can both be moved, rotated.
Claim(s) 6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wada et al., US 2003/0027225 in view of Reed as applied above, and further in view of Shinobu et al. 2011/0316522.
Wada in view of reed does not disclose a resonator surface and TFBAR sensor.
Shinobu discloses a sensing device that comprises a channel and a piezoelectric sensor 1700 forming a part of the channel and between first and second port (resonator sensor; TFBAR, Abstract; paragraphs [0018, 23; 75-77, 89 Figures 2-3, 6, 18, 30-32). The sensor allows for the detection of solution flowing through the channel.
It would have been obvious to one of ordinary skill in the art at before the effective filing date of the invention to incorporate a piezoelectric/TFBAR sensor device as a part of a channel of Wada to measure solutions flowing through the channel as taught by Shinobu.
Allowable Subject Matter
Claims 10, 16-17, and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798