DETAILED CORRESPONDENCE
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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7, drawn to a microfluidic device, classified in B01L3/5027.
II. Claims 8-11, drawn to a method for mixing, classified in B01F31/22.
The inventions are independent or distinct, each from the other because:
Inventions of group I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus of group I can be used to practice a different method such as storing a singular fluid in a channel without mixing, and only rotating clockwise without counter rotating.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
a. The inventions have acquired a separate status in the art in view of their different classification; and/or
b. The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
c. The inventions require a different field of search (for example, searching different class/subclasses or electronic resources, or employing different search strategies or search queries); and/or
d. The prior art applicable to one invention would not likely be applicable to another invention; and/or
e. The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Gray Mitchell on 10/6/25 a provisional election was made without traverse to prosecute the invention of group I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/24/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-11 are pending with claims 1-8 being examined and claims 9-11 deemed withdrawn.
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 1-7 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 pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear where the preamble begins or ends, or if there is even a claim body because there does not appear to be a transitional phrase that separates the claim body from the preamble. The claims recite a microfluidic device for missing, and then later sate that the microfluidic channel network comprising at least one microstructure, but it is unclear whether the term “comprising” is defining the network or if “comprising” is the transitional phrase that separates the claim body from the microfluidic device in the preamble.
Regarding claim 1, it is unclear how the channel can extend clockwise/counterclockwise with respect to the chamber as recited in lines 6-7. Specifically, it is unclear how any two structures can be clockwise/counterclockwise to each other without further clarification of the structure itself or without reference points. Any two structures that are distinct are separated from each other and could be clockwise or counterclockwise from each other depending on the direction. Further, if there are multiple channels, are the multiple channels all the same direction or could they be in different directions?
As to claim 1, the term “bowed in a clockwise or counter clockwise direction” in lines 7-8 is unclear. Specifically, what is “bowed” and how is something bowed in a direction without further reference or clarification. Additionally, is the channel bowed in that the inner diameter gets larger?
Claims 2-7 are rejected based on further claim dependency.
As to claim 7, “the bonding layer” is unclear as no bonding layer has been previously recited. Therefore, there is insufficient antecedent basis for the limitation and it is unclear what is attempting to be referred to. Further, it is unclear how this layer is different from the first substrate and second substrate which are joined together in claim 1.
As to claim 7, it is unclear what “if present” is describing in relation to when the bonding layer would or would not be present. The examiner requests clarification as to what the bonding layer is and whether it is or is not part of the device.
Appropriate correction and/or clarification is required.
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 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.
Claims 1-7 are rejected under 35 U.S.C. 102a2 as being anticipated by Cote, R (US 20230375394; hereinafter “Cote”).
As to claim 1, Cote teaches a microfluidic device for mixing and distributing fluids, formed by bonding of a first substrate and a second substrate, wherein open formations on the bonded first and second substrate for at least part of a microfluidic channel network comprising at least one microstructure comprising a single receiving chamber which is connected by at least one first channel extending from said single receiving chamber leading into an at least first target chamber, wherein the at least one first channel extends clockwise or counter clockwise from the single receiving chamber and is bowed in a clockwise or counter clockwise direction (Cote teaches multiple substrates 136/138 that are bonded together; Fig. 1-8, [65, 66]. Cote teaches a receiving chamber 110/112/130/132/134 that connects via channel 124 to a target chamber 116/120; [36, 38]. Cote teaches the channel can be various shapes and can include multiple channels and holds a microvolume; [38, 39, 40]. As best understood, Cote teaches the channel is bowed/curved and extends clockwise/counterclockwise).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Cote teaches the microfluidic device of claim 1, comprising at least one vent passing through the first substrate above the at least first target chamber for ventilating the respective target chamber (Cote teaches vent as 110 or 116/118, and also teaches a vent at target chamber; Fig. 1-5, [35, 55-56]).
As to claim 3, Cote teaches the microfluidic device of claim 1, wherein the first substrate is located above the second substrate (Cote teaches multiple substrates 136/138 that are bonded together; Fig. 1-8, [65, 66]).
As to claim 4, Cote teaches the microfluidic device of claim 1, wherein a bonding layer is arranged between bonded first and second substrate (Cote teaches multiple substrates 136/138 that are bonded together the portion at which they are bonded forming a layer; Fig. 1-8, [65, 66]).
As to claim 5, Cote teaches the microfluidic device of claim 1, wherein the single receiving chamber is arranged centrally on the microfluidic device (Cote teaches a receiving chamber 110/112/130/132/134; [36, 38]).
As to claim 6, Cote teaches the microfluidic device of claim 1, wherein an inner surface of the at least one channel is hydrophobic (Cote; [41, 55, 56]).
As to claim 7, Cote teaches the microfluidic device of claim 1, wherein the single receiving chamber is formed by openings in the first and second substrate, and if present by an opening in the bonding layer (Cote teaches the receiving chamber 110/112/130/132/134; [36, 38], Fig. 1-5).
Claims 1-7 are rejected under 35 U.S.C. 102a2 as being anticipated by Reiserer et al (US 20230338949; hereinafter “Reiserer”).
As to claim 1, Reiserer teaches a microfluidic device for mixing and distributing fluids (Reiserer; Title, Fig. 3I-3Q), formed by bonding of a first substrate and a second substrate, wherein open formations on the bonded first and second substrate for at least part of a microfluidic channel network comprising at least one microstructure comprising a single receiving chamber which is connected by at least one first channel extending from said single receiving chamber leading into an at least first target chamber, wherein the at least one first channel extends clockwise or counter clockwise from the single receiving chamber and is bowed in a clockwise or counter clockwise direction (Reiserer teaches multiple layers forming the device, and where all layers are bonded; Fig. 3D-3C, [174]. Reiserer teaches a central receiving chamber in Fig 3Q with channels that spiral outward to respective target chambers; [166, 168, 171, 189], Fig. 3K and 3Q).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Reiserer teaches the microfluidic device of claim 1, comprising at least one vent passing through the first substrate above the at least first target chamber for ventilating the respective target chamber (Reiserer teaches that fluid can flow either inwards or outwards and in order for fluid to flow in a conduit then it would need to be vented in the direction it was flowing to; [166, 168, 171, 189]).
As to claim 3, Reiserer teaches the microfluidic device of claim 1, wherein the first substrate is located above the second substrate (Reiserer teaches multiple layers forming the device, and where all layers are bonded; Fig. 3D-3C, [174]).
As to claim 4, Reiserer teaches the microfluidic device of claim 1, wherein a bonding layer is arranged between bonded first and second substrate (Reiserer teaches multiple layers forming the device, and where all layers are bonded; Fig. 3D-3C, [174]).
As to claim 5, Reiserer teaches the microfluidic device of claim 1, wherein the single receiving chamber is arranged centrally on the microfluidic device (Reiserer teaches a central receiving chamber in Fig 3Q with channels that spiral outward to respective target chambers; [166, 168, 171, 189], Fig. 3K and 3Q).
As to claim 6, Reiserer teaches the microfluidic device of claim 1, wherein an inner surface of the at least one channel is hydrophobic (Reiserer teaches elastomeric materials which are hydrophobic; [168]).
As to claim 7, Reiserer teaches the microfluidic device of claim 1, wherein the single receiving chamber is formed by openings in the first and second substrate, and if present by an opening in the bonding layer (Reiserer teaches multiple layers forming the device with openings, and where all layers are bonded; Fig. 3D-3C, [174]).
Claims 1-5, 7 are rejected under 35 U.S.C. 102a2 as being anticipated by Fair et al (US 20230234057; hereinafter “Fair”).
As to claim 1, Fair teaches a microfluidic device for mixing and distributing fluids (Fair; Fig. 8c, [124]), formed by bonding of a first substrate and a second substrate, wherein open formations on the bonded first and second substrate for at least part of a microfluidic channel network comprising at least one microstructure comprising a single receiving chamber which is connected by at least one first channel extending from said single receiving chamber leading into an at least first target chamber, wherein the at least one first channel extends clockwise or counter clockwise from the single receiving chamber and is bowed in a clockwise or counter clockwise direction (Fair teaches an enclosed microchannel with a central inlet chamber 854 that connects to a syringe where the fluid passes through spiral channels 872 and then to outlet chamber(s) 856/876; [195-200, 210], Fig. 8c. Fair teaches a substrate on one side of the channels and a substrate on the other side of the channels to form and enclose the microfluidic network. How the microfluidic network is formed is a matter of product by process. The device of Fair, because it is enclosing and forms channels such that there is structure on either side of the channel, would result in the same structure and function as two separate layers that are joined to form the channels because both methods produce microfluidic channels. Product-by-process claims are not limited to the manipulations of the recited steps, only to the resulting structure or structure implied by the steps. MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Fair teaches the microfluidic device of claim 1, comprising at least one vent passing through the first substrate above the at least first target chamber for ventilating the respective target chamber (Fair teaches that fluid can flow outwards to the target chambers and in order for fluid to flow in a conduit then it would need to be vented in the direction it was flowing to; [195-200, 210], Fig. 8c).
As to claim 3, Fair teaches the microfluidic device of claim 1, wherein the first substrate is located above the second substrate (Fair teaches a substrate on one side of the channels and a substrate on the other side of the channels to form and enclose the microfluidic network. How the microfluidic network is formed is a matter of product by process. The device of Fair, because it is enclosing and forms channels such that there is structure on either side of the channel, would result in the same structure and function as two separate layers that are joined to form the channels because both methods produce microfluidic channels. Product-by-process claims are not limited to the manipulations of the recited steps, only to the resulting structure or structure implied by the steps. MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As to claim 4, Fair teaches the microfluidic device of claim 1, wherein a bonding layer is arranged between bonded first and second substrate (Fair teaches a substrate on one side of the channels and a substrate on the other side of the channels to form and enclose the microfluidic network, and the bonding layer is just the region of space in the middle where the channel is. How the microfluidic network is formed is a matter of product by process. The device of Fair, because it is enclosing and forms channels such that there is structure on either side of the channel, would result in the same structure and function as two separate layers that are joined to form the channels because both methods produce microfluidic channels. Product-by-process claims are not limited to the manipulations of the recited steps, only to the resulting structure or structure implied by the steps. MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As to claim 5, Fair teaches the microfluidic device of claim 1, wherein the single receiving chamber is arranged centrally on the microfluidic device (Fair teaches an enclosed microchannel with a central inlet chamber 854 that connects to a syringe where the fluid passes through spiral channels 872 and then to outlet chamber(s) 856/876; [195-200, 210], Fig. 8c).
As to claim 7, Fair teaches the microfluidic device of claim 1, wherein the single receiving chamber is formed by openings in the first and second substrate, and if present by an opening in the bonding layer (Fair teaches teaches openings for fluid input and retrieval; Fig. 8c).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fair et al (US 20230234057; hereinafter “Fair”).
As to claim 6, Fair teaches the microfluidic device of claim 1, with the inner surface of the at least one channel (see above).
Fair does not specifically teach the inner surface of the channel is hydrophobic. However, it would have been obvious to one of ordinary skill in the art, depending on the type of sample being processed to have modified the channel of Fair to be hydrophobic because one of ordinary skill in the art would understand that using hydrophobic materials would prevent the samples from adhering to the wall and therefore help to control fluid flow.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Yung et al (US 20150367345; hereinafter “Yung”) teaches a central inlet hole 108 with spiral channels 128; Fig. 1. Yung shows that there are multiple layers to the device that are bonded together in Figure 2.
Li et al (US 20100041562; hereinafter “Li”) teaches a central hole with spiral channels that extend outwardly where there are multiple layers that make up the device; Figs. 1, 2, 3, 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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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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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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