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 .
Election/Restrictions
Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 MAY 2026.
Applicant’s election without traverse of Group I: Claims 1-15, 17, 18, 26 and 27 in the reply filed on 26 MAY 2026 is acknowledged.
Status of Claims
In the election on 26 MAY 2026; Applicant has elected without traverse of Group I: Claims 1-15, 17, 18, 26 and 27.
Claims 16, 19-25 and 29-61 are ‘Canceled’; and Claim 28 is ‘Withdrawn’.
Current pending claim for consideration are Claims 1-15, 17, 18, 26 and 27 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07 AUGUST 2023 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.
The information disclosure statement (IDS) submitted on 19 JULY 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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1A, character 27, 27’ , 27”, 24’, 22” ; Figure 6A, character 600. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 6B, [0135], character 621, 623. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 13, 18, 26 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "the cross-sectional area of buffer channel". There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the second membrane region" . There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the second retentate output". There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the dilution buffer input". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-11, 14, 15, 17, 18, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over ZHANG, US Publication No. 2010/0300882 A1, submitted on the Information Disclosure Statement on 07 AUGUST 2023, US Patent Application Publications, and further in view of TONER, US Publication No. 2006/0134599 A1, submitted on the Information Disclosure Statement on 07 AUGUST 2023, US Patent Application Publications.
Applicant’s invention is directed towards an apparatus, a microfluidic apparatus.
Regarding Claim 1, the reference ZHANG discloses a microfluidic apparatus, abstract, Figure 1-3, the apparatus comprising:
a first concentrator region , Figure 3, [0049], tangential flow component 56, comprising: a first permeate channel that extends in a first pathway in a first layer, Figure 3, upper channel 70, [0049], first feed channel that extends in the first pathway in a second layer from a feed input to a first retentate output, Figure 3, channel 72 from inlet 62 to outlet 64, [0049] , wherein the first permeate channel extends adjacent to the first feed channel, Figure 3, channel 70 and 72 extending adjacent each other in horizontal direction, and a first membrane region that separates the first permeate channel from the first feed channel, Figure 3, membrane 74, separates channel 70 and 72, [0049]; a buffer input downstream the first retentate output for adding buffer into a retentate leaving the first feed channel, Figure 3 inlet 88, [0045]; and a second concentrator region in fluid communication with the first retentate output, Figure 3, component 58 in communication with outlet 64, [0049].
The ZHANG reference discloses the claimed invention, but is silent in regards to a serpentine pathway.
The TONER reference discloses a microfluidic apparatus, abstract, [0010], Figure 1, the apparatus comprising: a first concentrator region comprising: a first permeate channel that extends in a first serpentine pathway in a first layer, Figure 1, card has a channels that extend in serpentine pathway, [0061], a first feed channel that extends in the first serpentine pathway, Figure 1, input channel , [0061], to a first output, Figure 1, output channel, [0061, 0062], wherein the first permeate channel extends adjacent to the first feed channel, Figure 1, see left side of card, and a first membrane region that separates the first permeate channel from the first feed channel, [0110], filter; a buffer input downstream the first retentate output for adding buffer into a retentate leaving the first feed channel, [0063].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify ZHANG with the serpentine pathway as taught by TONER to reduce the total footprint of the device or to introduce chaotic advection for enhanced mixing, TONER [0063].
Additional Disclosures Included are: Claim 2: wherein the apparatus of claim 1, wherein a cross-sectional area of first feed channel decreases along the first serpentine pathway from the feed input to the first retentate output to maintain a constant shear rate within the first feed channel, ZHANG, Figure 3, see cross section of channel 72 from inlet 62 to outlet 64.; Claim 3: wherein the apparatus of claim 1, wherein a height of the first feed channel shortens along the first serpentine pathway from the feed input to the first retentate output, ZHANG, Figure 3, see height of channel 72 from inlet 62 to outlet 64. ; Claim 10: wherein the apparatus of claim 1, wherein the first membrane region is permeable to ethanol. The instant claim language does not further define structurally, but rather a property of the membrane. It is known in the art that all membranes are inherently permeable to certain substances, but not all. The permeability is a property that allow the membrane to act as selective barriers. The membrane as taught by ZHANG has a portion that is functionalized and it is functionalized to modulate at least one of the membrane properties selected from the pore size, modify charge of the pore, adjust surface adsorption, or modulate the wettability of the membrane, Claims 4, 5, 19, [0039]. Since ZHANG discloses that the membrane can be functionalized , it would be obvious to one having ordinary skill in the art before the effective filing date to modify the membrane so that it permeable to ethanol allow passage of passage of small molecules .; Claim 11: wherein the apparatus of claim 1, further comprising a feed input port fluidly connected with the feed input and a retentate output port fluidly connected with the second concentrator region, ZHANG, [0040], at least one inlet, it is interpreted by the Examiner that at least one of the inlet is capable to be a feed input port.; Claim 17: wherein the apparatus of claim 1, wherein a height of the first feed channel shortens along the first serpentine pathway from the feed input to the first retentate output and wherein a height of the second feed channel shortens along the second serpentine pathway from an output of the dilution buffer region to the second retentate output, ZHANG, Figure 3, see cross section of channel 72 from inlet 62 to outlet 64 in components 56 and 58. ; Claim 18: wherein the apparatus of claim 1, wherein the first membrane region and the second membrane region are parts of a single membrane, Figure 3. ; Claim 26; wherein the apparatus of claim 1, further comprising a feed input port fluidly connected with the feed input and a retentate output port fluidly connected with the second retentate output, ZHANG, [0040], at least one inlet, it is interpreted by the Examiner that at least one of the inlet is capable to be a feed input port connected with membrane 74 an outlet.; and Claim 27: wherein the apparatus of claim 1, further comprising a permeate output out of the first permeate channel at approximately the dilution buffer input, ZHANG, [0040], at least one outlet, can be any one of 64/68/86 or 90.
Regarding Claim 7, the combination suggests the claimed invention, but is silent in regards to wherein the first serpentine pathway has a length of greater than about 5 meters.
The TONER reference which teaches the serpentine channel/pathway defines the “serpentine channel” is meant a channel that has a total length that is greater than the linear distance between the end points of the channel. A serpentine channel may be oriented entirely vertically or horizontally. Alternatively, a serpentine channel may be “3D,” e.g., portions of the channel are oriented vertically and portions are oriented horizontally, [0017, 0063].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the length of the first serpentine pathway has a length of greater than about 5 meters to enable optimal processing throughput , [0063] or to introduce chaotic advection for enhanced mixing, [0063].
Regarding Claim 8, the references ZHANG and TONER suggest the claimed invention, but is silent in regards to wherein the first membrane region has an area of greater than about 50 cm2.
However, ZHANG teaches the membrane has a size in a range from about 100 microns by 100 microns or 1 micron to about 1 centimeter in diameter, [0028, 0036]. ZHANG further suggests the number of membranes may be modified including a plurality of membranes, [0029]. TONER teaches the overall size of the device to have a length of 10 cm and width of 5 cm, [0087]. TONER further suggest the design is flexible enough to accommodate larger or smaller sizes for different applications, [0087, 0088].
While ZHANG teaches the membrane to be used in a microfluidic device and TONER teaches the overall size of the device to be modified for different applications and the number of membrane may be increased, it would be obvious to one having ordinary to modify the first membrane region has an area of greater than about 50 cm2 to tune the membrane for strength and robustness, [0029], and to increase the size of the area for capturing the target of interest.
Regarding Claim 9 , the combination above suggests the claimed invention, but is silent in regards to wherein the first membrane region comprises a Polyethersulfone (PES), a Composite Regenerated Cellulose (CRC) membrane, or a combination thereof.
The membrane as taught by ZHANG has a portion that is functionalized and it is functionalized to modulate at least one of the membrane properties selected from the pore size, modify charge of the pore, adjust surface adsorption, or modulate the wettability of the membrane, Claims 4 and 5, [0039]. ZHANG further teaches the membrane may be made modified including it wettability characteristics, [0034].
Since ZHANG teaches the membrane may be functionalized and/or its wettability may be modified, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention so that the first membrane region comprises a Polyethersulfone (PES), a Composite Regenerated Cellulose (CRC) membrane, or a combination thereof to improve wettability or hydrophilicity of membrane surfaces, [0034].
Applicant’s invention is directed towards an apparatus.
Regarding Claim 14, the ZHANG reference discloses an apparatus, abstract, Figure 1-3, comprising:
a first concentrator region , Figure 3, [0049], flow component 56, comprising: a first permeate channel that extends in a first pathway in a first layer, Figure 3, upper channel 70, [0049], a first feed channel that extends in the first serpentine pathway in a second layer from a feed input to a first retentate output, Figure 3, channel 72 from inlet 62 to outlet 64, [0049], wherein the first permeate channel extends adjacent to the first feed channel, Figure 3, channel 70 and 72 extend adjacent each other in horizontal direction, and a first membrane region that separates the first permeate channel from the first feed channel, Figure 3, inlet 88, [0045];
a dilution buffer region in fluid communication with the first retentate output of the first feed channel, Figure 3 inlet 88 [0045]; and
a dilution buffer input into the dilution buffer region, [0040]; and
a second concentrator region, Figure 3, component 58 in communication with outlet 64, [0049], comprising: a second permeate channel, Figure 3, lower channel 94, that extends in a second pathway in the first layer, Figure 3, channel 92 extends in second horizontal pathway in first upper layer, a second feed channel in fluid communication with an output of the dilution buffer region, Figure 3, channel 94 in communication with outlet 90, [0045], as well as Figure 1, outlet 16 in lower channel use to draw out buffer, [0045], wherein the second feed channel extends in the second serpentine pathway in the second layer, Figure 3, channel 94 extending in second horizontal pathway in second lower layer, wherein the second permeate channel extends adjacent to the second feed channel, Figure 3, channel 92 and 94 extend adjacent each other in horizontal direction, and a second membrane region that separates the first permeate channel from the second feed channel; and a second retentate output in fluid communication with the second feed channel, Figure 3, membrane 96, [0049].
The ZHANG reference discloses the claimed invention, but is silent in regards to a serpentine pathway.
The TONER reference discloses a microfluidic apparatus, abstract, [0010], Figure 1, the apparatus comprising: a first concentrator region comprising: a first permeate channel that extends in a first serpentine pathway in a first layer, Figure 1, card has a channels that extend in serpentine pathway, [0061], a first feed channel that extends in the first serpentine pathway, Figure 1, input channel , [0061], to a first output, Figure 1, output channel, [0061, 0062], wherein the first permeate channel extends adjacent to the first feed channel, Figure 1, see left side of card, and a first membrane region that separates the first permeate channel from the first feed channel, [0110], filter; a buffer input downstream the first retentate output for adding buffer into a retentate leaving the first feed channel, [0063].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify ZHANG with the serpentine pathway as taught by TONER to reduce the total footprint of the device or to introduce chaotic advection for enhanced mixing, TONER [0063].
Additional Disclosure Included is: Claim 15: wherein the apparatus of claim 14, wherein a cross-sectional area of first feed channel decreases along the first serpentine pathway from the feed input to the first retentate output to maintain a constant shear rate within the first feed channel, ZHANG, Figure 3, see cross section of channel 72 from inlet 62 to outlet 64.
Claims 4-6 are obvious over ZHANG, US Publication No. 2010/0300882 A1, submitted on the Information Disclosure Statement on 07 AUGUST 2023, US Patent Application Publications, and further in view of TONER, US Publication No. 2006/0134599 A1, submitted on the Information Disclosure Statement on 07 AUGUST 2023, US Patent Application Publications, and further in view of MASQUELIER, US Patent 10,532,324 B1, submitted on the Information Disclosure Statement on 19 JULY 2024, US Patents.
Regarding Claim 4, the combination above suggests the claimed invention, but is silent in regards to wherein the apparatus further comprises a pressure- distributing seal that distributes pressure to seal the first membrane region between the first layer and the second layer.
The MASQUELIER reference discloses a microfluidic apparatus, Figure 4A-C, the apparatus comprising: a first concentrator region, Figure 4C, retentate member 404, comprising a first permeate channel in a first layer, a first feed channel in a second layer and a first membrane region, Figure 4C, 411/409/403, Column 40 line 11-58, and further comprising: a pressure- distributing seal that distributes pressure to seal the first membrane region between the first layer and the second layer, Figure 4C, gasket 416, Column 40 line 29.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the combination above with the pressure distributing seal taught by MASQUELIER to surround each member of the device, secure members of the device and to provide a leak proof seal between members, Column 40 line 29-58.
Additional Disclosures Included are: Claim 5: wherein the apparatus of claim 4, wherein the pressure-distributing seal comprises a sheet of compressive foam, Column 39 line 65-Column 40 line 2. ; and Claim 6: wherein the apparatus of claim 4, wherein the pressure-distributing seal comprises a pressurizing chamber, Figure 4Z, Column 51 line 10-14.
Allowable Subject Matter
Claims 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 12, the combination above suggests the claimed invention. ZHANG further teaches the buffer input is fluidly connected with a buffer channel that extends in a second pathway [0040], at least one inlet, one or more additional channels, but is silent in regards to a third layer. There is not teaching or suggestion to provide an additional layer in Figure 3 or duplicate the number of flow components, such as 56 or 58, so that there is/are additional inputs and channels. ZHANG further is silent in regards to the structural limitation of wherein the buffer channel extends adjacent to a second feed channel that is in fluid communication with the first retentate output, and wherein the second feed channel is separated from a second permeate channel by a second membrane region on a first side of the second feed channel, and the second feed channel is separated from the buffer channel by a third membrane region on a second side of the second feed channel is not found or suggested in the prior art.
Dependent claim 13 is directly dependent upon Claim 12 and is also objected to.
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
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