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 .
Status of Claims
The claim set submitted on 18 MAY 2023 is acknowledged and considered. In the claim set, Claims 1-20 are presented and considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 JANUARY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The use of the term OSTMER®, [0025], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 “sensor device is configured to ….detect at least a sensed property” in Claim 1.
A “device” does not connote any particular structure. The “sensor device” is described as an independent sensor or an optical device, [0020, 0022, 0023].
An “external device…configured to connect the at least two active flow components using at least a mechanical interface; and initiate a plurality of active flow processes corresponds to the plurality of assay steps as a function of the at least two active flow components” in Claim 1.
A “device” does not connote any particular structure. The “external device” is any equipment, instrument, or system, [0026], includes at least two actuators, [0027], Claim 1, includes a reading device 156 communicatively connected to at least a sensor device 132, [0045].
An “actuators are configured to …connect the at least two active flow components…and initiate a plurality of active flow processes” in Claim 1.
An “actuator” does not connote any particular structure. The “actuator” is described as “device that produces a motion by converting energy and signals going into the system.” and may include “a component of a machine that is responsible for moving and/or controlling a mechanism or system.”, [0027].
A “reading device … configured to read the at least a sensed property of the at least a fluid from the at least a sensor device” in Claim 1.
A “device” does not connote any particular structure. The “reading device” is “may include any computing device as described in this disclosure, including without limitation a microcontroller, microprocessor, digital signal processor (DSP) and/or system on a chip (SoC)”, [0045].
An “active flow component … configured to flow the at least a fluid bi-directionally through the at least a sensor device within the microfluidic environment as a function of the plurality of active flow processes.” in Claim 1 and “active flow component is configured to flow the at least a fluid in a first direction within the microfluidic environment under the first operation mode” and “active flow component is configured to flow the at least a fluid in a second direction within the microfluidic environment under the second operation mode” in Claim 17.
A “component” does not connote any particular structure. The “active flow component” is a barrel and a plunger within the barrel, Claim 3.
A “passive flow component configured to flow the at least a fluid unidirectionally through the at least a sensor device within the microfluidic environment as a function of a passive flow process” in Claim 10.
A “component” does not connote any particular structure. The “passive flow component” is a “may include a capillary pump”, [0059], and employ one or more passive flow techniques in order to initiate passive flow process; for instance, and without limitation, passive flow techniques may include osmosis, capillary action, surface tension, pressure, gravity-driven flow, hydrostatic flow, vacuums, and the like, [0058].
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 § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-3, 5-9, 11-13, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BENAM , US Publication No. 2018/0080925 A1.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the BENAM reference discloses an apparatus for controlling assay steps within an assay using a plurality of active flow components, , abstract, microfluidic system, the apparatus comprises:
a microfluidic device comprising a plurality of microfluidic features, Figure 1, [0044], organ on chip device, 10, wherein the plurality of microfluidic features comprises: at least a reservoir configured to contain at least a fluid, Figure 2, chamber is created by channels 34 and 36, [0050]; and
a plurality of microfluidic channels connected to the at least a reservoir, Figure 2, channels 30, 31, 32, 33, 34, [0044] , wherein the plurality of micro fluidic channels is configured to: create a microfluidic environment for an assay, [0044, 0045], comprising a plurality of assay steps, Claims 31-41;
at least two active flow components fluidically connected to the plurality of microfluidic features, [0013, 0014], syringe/plunger, Figure 3A, Claim 14 ;
at least a sensor device, [0050], wherein the at least a sensor device is configured to: be in sensed communication with the at least a fluid, [0044, 0045]; and detect at least a sensed property of the at least a fluid , [0045]; and
an external device connected to the microfluidic device using at least an alignment feature, Figure 3, carrier substrate, [0103] and controller [0066], wherein the external device comprises: at least two actuators, wherein the at least two actuators are configured to: connect the at least two active flow components using at least a mechanical interface; and initiate a plurality of active flow processes corresponds to the plurality of assay steps as a function of the at least two active flow components, [0066], motor of pump is connected to controller, controller comprises one or more processors; and
at least a reading device communicatively connected to the at least a sensor device, [0066-0072], wherein the at least a reading device is configured to: read the at least a sensed property of the at least a fluid from the at least a sensor device; wherein the at least two active flow components are configured to: flow the at least a fluid bi-directionally through the at least a sensor device within the microfluidic environment as a function of the plurality of active flow processes, [0071-0074].
Additional Disclosures Included are: Claim 2: wherein the apparatus of claim 1, wherein the plurality of microfluidic features comprises a microfluidic flow regulator, Figure 5, valves, [0084, 0092, 0094, 0097].; Claim 3: wherein the apparatus of claim 1, wherein each active flow component of the at least two active flow components comprise a barrel and a plunger within the barrel, [0014].; Claim 5: wherein the apparatus of claim 1, wherein the at least a mechanical interface comprises a multiple plunger grabbing mechanism, Figure 3F, [0058-0062].; Claim 6: wherein the apparatus of claim 1, wherein each actuator of the at least two actuator comprises a linear actuator, Figure 3F, [0058].; Claim 7: wherein the apparatus of claim 1, wherein each active flow component of the at least two active flow components comprise: a first operation mode comprising a pull regime, wherein the active flow component is configured to flow the at least a fluid in a first direction within the microfluidic environment under the first operation mode; and a second operation mode comprising a push regime, wherein the active flow component is configured to flow the at least a fluid in a second direction within the microfluidic environment under the second operation mode; wherein: the first direction is a direction towards the active flow component; and the second direction is a direction towards the at least a reservoir, [0014, 0062, 0063]. ; Claim 8: wherein the apparatus of claim 7, wherein initiating the plurality of active flow processes corresponds to the plurality of assay steps comprises: actuating the pull regime using a first actuator connected to a first active flow component; actuating the push regime using a second actuator connected to a second active flow component; and creating a fluid flow path within the microfluidic environment for the at least a fluid, [0062, 0063]. ; and Claim 9: wherein the apparatus of claim 7, wherein initiating the plurality of active flow processes corresponds to the plurality of assay steps comprises: actuating the push regime using the at least two actuators connected to the at least two active flow components; and mixing a first fluid stored in a first active flow component with a second fluid stored in the second active flow component, Figure 3F, [0059-0063].
Applicant’s invention is directed to a method.
Regarding Claim 11, the reference BENAM discloses a method for controlling assay steps within an assay using a plurality of active flow components, abstract, [0007], the method comprises: creating, by a microfluidic device comprising a plurality of microfluidic features, Figure 1, [0044], organ on chip device, 10, a microfluidic environment for an assay containing a plurality of assay steps, [0016, 0017], wherein the plurality of microfluidic features comprises: at least a reservoir configured to contain at least a fluid, Figure 2, chamber is created by channels 34 and 36, [0050]; and a plurality of microfluidic channels connected to the at least a reservoir, Figure 2, channels 30, 31, 32, 33, 34, [0044]; initiating, by at least two actuators within an external device, , Figure 3, carrier substrate, [0103] and controller [0066], a plurality of active flow processes corresponds to the plurality of assay steps as a function of at least two active flow components fluidically connected to the plurality of microfluidic features, [0044, 0045], Claims 31-41, wherein: the at least two actuators are connected to the at least two active flow components using at least a mechanical interface, [0066], motor of pump is connected to controller, controller comprises one or more processors; and the external device is connected to the microfluidic device using at least an alignment feature, [0066], motor of pump is connected to controller, controller comprises one or more processors, Figure 3, carrier substrate, [0103] and controller [0066]; flowing, by the at least two active flow components, the at least a fluid bi-directionally through at least a sensor device within the microfluidic environment as a function of the plurality of active flow process; detecting, by the at least a sensor device, at least a sensed property of the at least a fluid; and reading, by a reading device of the external device, the at least a sensed property of the at least a fluid from the at least a sensor device, [0016, 0052, 0066-0074].
Additional Disclosures Included are: Claim 12: wherein the method of claim 11, wherein the plurality of microfluidic features comprises a microfluidic flow regulator, , Figure 5, valves, [0084, 0092, 0094, 0097].; Claim 13: wherein the method of claim 11, wherein each active flow component of the at least two active flow components comprise a barrel and a plunger within the barrel, [0014].; Claim 15: wherein the method of claim 11, wherein the at least a mechanical interface comprises a multiple plunger grabbing mechanism, Figure 3F, [0058-0062]. ; Claim 16: wherein the method of claim 11, wherein each actuator of the at least two actuator comprises a linear actuator, Figure 3F, [0058]. ; Claim 17: wherein the method of claim 11, wherein each active flow component of the at least two active flow components comprise: a first operation mode comprising a pull regime, wherein the active flow component is configured to flow the at least a fluid in a first direction within the microfluidic environment under the first operation mode; and a second operation mode comprising a push regime, wherein the active flow component is configured to flow the at least a fluid in a second direction within the microfluidic environment under the second operation mode; wherein: the first direction is a direction towards the active flow component; and the second direction is a direction towards the at least a reservoir, [0014, 0062, 0063]. ; Claim 18: wherein the method of claim 17, wherein initiating the plurality of active flow processes corresponds to the plurality of assay steps comprises: actuating the pull regime using a first actuator connected to a first active flow component; actuating the push regime using a second actuator connected to a second active flow component; and creating a fluid flow path within the microfluidic environment for the at least a fluid, [0062, 0063].; and Claim 19: wherein the method of claim 17, wherein initiating the plurality of active flow processes corresponds to the plurality of assay steps comprises: actuating the push regime using the at least two actuators connected to the at least two active flow components; and mixing a first fluid stored in a first active flow component with a second fluid stored in the second active flow component within the microfluidic environment, Figure 3F, [0059-0063].
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 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over BENAM , US Publication No. 2018/0080925 A1 and further in view of VAN HERREN, Henne, Lab Chip, 2012, 12, 1022–1025.
Regarding Claims 4 and 14, the inventions directed to microfluidic apparatus and method of Claims 1 and 11, respectively, are anticipated by BENAM, above, but is silent in regards to wherein the alignment feature comprises a multi-fiber push connector (MPO).
The VAN HERREN reference discloses well-known microfluidic apparatus, abstract, for controlling assay steps within an assay using a plurality of active flow components, page 1022, middle column, active flow components between pumps, sensors and reactors. The microfluidic apparatus includes alignment features, which comprises a multi-fiber push connector (MPO), Figure 3, page 1025, let column.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the BENAM reference with the alignment feature comprising a multi-fiber push connector as taught by VAN HERREN to ensure proper alignment and to have the device work at higher temperature and pressure regimes and show smaller dead volumes compared to, for instance, ferrule based connectors, page 1025, left column.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over BENAM , US Publication No. 2018/0080925 A1, and further in view of LINDER, US Publication No. 2008/0273918 A1.
Regarding Claims 10 and 20, the inventions directed to microfluidic apparatus and method of Claims 1 and 11, respectively, are anticipated by BENAM, above, but is silent in regards to the apparatus and method further comprises: a passive flow component configured to flow the at least a fluid unidirectionally through the at least a sensor device within the microfluidic environment as a function of a passive flow process.
The LINDER reference discloses a well-known microfluidic apparatus for controlling assay steps within an assay using a plurality of active flow components, abstract, microfluidic system, the apparatus comprises: a microfluidic device comprising a plurality of microfluidic features, Figure 7A-D, [0091], wherein the plurality of microfluidic features comprises: at least a reservoir configured to contain at least a fluid, [0090]; and a plurality of microfluidic channels connected to the at least a reservoir, [0090-0091, 0095], Figure 7A-D, wherein the plurality of micro fluidic channels is configured to: create a microfluidic environment for an assay comprising a plurality of assay steps, [0090-0101]; at least two active flow components fluidically connected to the plurality of microfluidic features, Figure 7A-D, inlets have plungers, [0072, 0085, 0090, 0091, 0195]; at least a sensor device, wherein the at least a sensor device is configured to: be in sensed communication with the at least a fluid, [0167]; and detect at least a sensed property of the at least a fluid, [0086, 0153, 0154]; and an external device connected to the microfluidic device using at least an alignment feature, [0168], and wherein the apparatus further comprises: a passive flow component configured to flow the at least a fluid unidirectionally through the at least a sensor device within the microfluidic environment as a function of a passive flow process, [0098, 0102, 0167].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the BENAM reference with the passive flow component configured to flow the at least a fluid unidirectionally through the at least a sensor device within the microfluidic environment as taught by LINDER to efficiently and controllably introducing fluid into a microfluidic device without the use of extra external devices such as pump and the passive flow component enables passive, pump-free fluid movement, leading to simpler, cheaper, portable, and autonomous devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797