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 .
Response to Amendment
As to applicants amended claims filed 7/13/26, most of the previous 112(b) rejections are withdrawn. However, new rejection(s) have been entered based on the claim amendments.
As to the claim amendments and remarks, the previous prior art rejection based on Cote is withdrawn. Based on the claim amendments and remarks, the other previous prior art rejections have been modified to address the claim amendments (see below).
Claim Status
Claims 1-11 are pending with claims 1-7 being examined and claims 8-11 deemed withdrawn.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 whether or not there are multiple first target chambers in line 8. The claim recites “a plurality of first target chamber”, where “plurality” implies multiple but “chamber” implies singular. The examiner believes applicants are attempting to claim “chambers”. Lending to the clarity issue is that claim 2 refers to a singular “the at least first target chamber” which is only one chamber. Claim 2 is also unclear because it is unclear if only a singular chamber is attempting to be referred to, or if all/each of the chambers are attempting to be referred to, or if potentially only one of a plurality is being referred to.
As to claim 1, it is unclear what applicants are referring to by “the at least one single receiving chamber” in line 9. There is also insufficient antecedent basis for any “singular” chamber. Previously, there is at least one receiving chamber in lines 5-6. However, it because unclear whether or not there is only a singular chamber or a plurality, since the claims recite “single” receiving chamber. Although the examiner believes applicants did not intend to include “single”, the claim remains contradictory whether or not the chamber is singular or potentially includes a plurality based on the nomenclature used.
Claims 2-7 are rejected based on further claim dependency.
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. If a bonding layer is present, where is this layer? Are applicant attempting to state that the bonding layer is between the first and second substrate? As drafted, the claim is unclear as to what a bonding layer is bonding. 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 § 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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Reiserer et al (US 20230338949; hereinafter “Reiserer” ; already of record) in view of Yung et al (US 20150367345; hereinafter “Yung”; already of record) in view of Nolan (US 20230249178; hereinafter “Nolan”).
As to claim 1, Reiserer teaches a system with a microfluidic device for mixing and distributing fluids, wherein the microfluidic device is formed by bonding of a first substrate and a second substrate, wherein open formations on the bonded first and second substrate of the microfluidic device form at least part of a microfluidic channel network which comprises at least one receiving chamber which is connected by a plurality of first channels extending from said at least one receiving chamber to a plurality of first target chamber(s), wherein each of the plurality of first channels extends clockwise or counter clockwise from the at least one single receiving chamber in a bow which is bent clockwise or counter clockwise (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.
Reiserer does not specifically teach an orbital shaker attached to the microfluidic device. However, Yung teaches the analogous art of a microfluidic device with a central inlet hole 108 with spiral channels 128 (Yung; Fig. 1), which is rotated to cause fluid flow (Yung; [6, 9, 10, 35, 36, 40]). It would have been obvious to have modified the microfluidic device that moves fluids of Reiserer to have been a spinning based device as in Yung because Yung teaches that a spinning device helps provide fluid flow (Yung; [6, 9, 10]).
Reiserer does not teach how the device spins or rotates. However, Nolan teaches the analogous art of microfluidic platforms, which can also include orbital shakers (Nolan; [192]). It would have been obvious to have modified the microfluidic device that moves fluids via spinning of modified Reiserer to have archived the fluid movement via an orbital shaker as in Nolan because Nolan teaches that it is well known for microfluidic platforms to also include orbital shakers (Nolan; [192]).
As to claim 2, Reiserer teaches the system 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 system 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 system 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 system 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 system 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 system 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fair et al (US 20230234057; hereinafter “Fair”; already of record) in view of Li et al (US 20100041562; hereinafter “Li”; already of record) in view of Nolan (US 20230249178; hereinafter “Nolan”).
As to claim 1, Fair teaches a system, with a microfluidic device for mixing and distributing fluids, wherein the microfluidic device is formed by bonding of a first substrate and a second substrate, wherein open formations on the bonded first and second substrate of the microfluidic device form at least part of a microfluidic channel network which comprises at least one receiving chamber which is connected by a plurality of first channels extending from said at least one receiving chamber to a plurality of first target chamber(s), wherein each of the plurality of first channels extends clockwise or counter clockwise from the at least one single receiving chamber in a bow which is bent clockwise or counter clockwise (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.
Although Fair teaches rotating vortices with respect to the device (Fair; [207, 220]), Fair does not specifically teach an orbital shaker attached to the microfluidic device. However, Li teaches the analogous art of a microfluidic device with a central hole with spiral channels that extend outwardly where there are multiple layers that make up the device (Li; Figs. 1, 2, 3, 9) which is then spun to cause fluid flow (Li; [57, 63, 65, 76]). It would have been obvious to have modified the microfluidic device that moves fluids of Fair to have been a spinning based device as in LI because Li teaches that a spinning device helps provide the advantage of decreasing need for complicated fluid handling (Li; [63]).
Fair does not teach how the device spins or rotates. However, Nolan teaches the analogous art of microfluidic platforms, which can also include orbital shakers (Nolan; [192]). It would have been obvious to have modified the microfluidic device that moves fluids via spinning of modified Fair to have archived the fluid movement via an orbital shaker as in Nolan because Nolan teaches that it is well known for microfluidic platforms to also include orbital shakers (Nolan; [192]).
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 system 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 system 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 system 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 6, Fair teaches the system of claim 1, with the microfluidic device with the inner surface of the each of the channels (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.
As to claim 7, Fair teaches the system 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 openings for fluid input and retrieval; Fig. 8c).
Response to Arguments
Applicant's arguments filed 7/13/26 have been fully considered, but they are moot as they are towards the claim amendments and not the current grounds of rejection.
The examiner notes that applicants amendments to the plurality of channels overcomes the Cote reference. The examiner also notes that applicants do not provide any other arguments against the other references or rejections of record. Although applicants argue that no structures are capable of mixing or transferring fluids by changing the direction of orbital movement, the examiner notes that these limitations are not in the claim and that the claims are directed towards a system and not a method.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
Prosecution Insights