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
Claims 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method and kit, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 22 JULY 2026.
Applicant's election with traverse of Group I: Claims 1-11 and 14-18 in the reply filed on 22 JULY 2026 is acknowledged. The traversal is on the ground(s) that the reference does not teach or suggest the shared technical feature. In the restriction, the Examiner mistakenly forgot one zero (0); however, the TONER reference based what is taught suggests the claimed invention where the L/D ratio ≥ 2000. See the rejection below.
The requirement is still deemed proper and is therefore made FINAL.
In addition, in Claim 15, the preamble recites ‘method according to claim 1’ which means it should be grouped with Group I; not Group II.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 OCTOBER 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.
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 1-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over TONER, WO 2015/116990 A1, submitted on the Information Disclosure Statement on 11 OCTOBER 2023.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the TONER reference discloses a method of separating particles in a microfluidic device, Examples 1, 5 and 6, the method comprising:
providing a microfluidic device comprising at least one microchannel, the microchannel comprising at least one first inlet and at least one first outlet, Figure 1, [0053], system w inlet 106/channel 104/outlet 108;
forming a mixture by suspending said particles in an aqueous viscoelastic liquid, abstract, [0003, 0016, 0051]; and
introducing said mixture into said microchannel via said first inlet and flowing said mixture through said microchannel at a flow rate (Q) of from 0.25 ml/min to 50 ml /min, Example 5 and 6, [00107-00114], characterised in that said microchannel satisfies the formula L/D, [0059], wherein L represents the length of said microchannel and D represents the cross-sectional diameter of said microchannel, and said viscoelastic liquid comprises from 0.15 wt.% to 0.55 wt.% xanthan gum or from 0.05 wt.% to 1.0 wt.% hyaluronic acid, [0098].
The TONER reference discloses the claimed invention, however, but it is silent in regards to wherein the characterised in that said microchannel satisfies the formula L/D > 2000. While TONER teaches the microchannel has a length L , such that the flow within the channel is laminar, [0059, 0060], and a cross-sectional diameter D, [0030], Figure 10A-D, inner diameter 50 mm.
TONER teaches a process for fabricating the microfluidic device that includes a microchannel which can be fabricating with a desired shape e.g., straight line or other shape, and desired dimension, e.g., desired length, width, or other dimension, [0056].
Therefore since TONER teaches and suggests the microchannels dimensions are result effective variables, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the length and cross-sectional diameter so that the microchannel is characterised in that it satisfies the formula L/D > 2000 so that particles within the microchannel can effectively be separated with sufficient spacing to minimize any multiparticle strings / agglomerates that disrupt the continuity of the particle trains, MPEP 2144.05(II) and 2143(I)(E).
Additional Disclosures Included are Claim 2: wherein the method according to claim 1, wherein said microchannel is curvilinear, [0011, 0056], and, optionally, has an inner radius of curvature of from 2.5 mm to 25 mm, Examiner’s Note: Since the claim language uses the term ‘optionally’; it is interpreted by the Examiner that it is not required. In addition, the instant claim language does not further limit the method of claim 1 and does not add any additional limitations to the method itself. ; Claim 3: wherein the method according to claim 1, wherein the cross-sectional diameter (D) of said microchannel is between 50 mm and 500 mm, [0096]. Examiner’s Note: The instant claim language does not further limit the method of claim 1 and does not add any additional limitations to the method itself.; Claim 4: wherein the method according to claim 1, wherein said microchannel has a circular cross section, [0011], Figure 10B, 10D. Examiner’s Note: The instant claim language does not further limit the method of claim 1 and does not add any additional limitations to the method itself.; Claim 5: wherein the method according to claim 1, wherein the length (L) of said microchannel is at least 100 mm, [0056], the length of channel can be of desired dimension, [0058, 00116], length is chosen so that there is laminar flow. However, TONER does not teach the length is at least 100 mm. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of TONE so that the length (L) of said microchannel is at least 100 mm so that particles within the microchannel can effectively be separated with sufficient spacing to minimize any multiparticle strings / agglomerates that disrupt the continuity of the particle trains and so that the flow within the channel is laminar, MPEP 2144.05(II) and 2143(I)(E).; Claim 7: wherein the method according to claim 1, wherein said mixture comprises said particles in an amount from 0.1 wt.% to 1 wt.% and/or wherein said particles have a cross sectional diameter (d) of from 10 mm to 30 pm, [0037-0039, 00101]. ; Claim 8: wherein the method according to claim 1, wherein said microchannel provides a confinement ratio b of from 0.15 to 0.5, calculated using the formula b = d/D wherein d represents the diameter of said particles in said mixture and D represents the cross-sectional diameter of said microchannel, [0011, 0030], diameter of the polystyrene beads can range between 1 mm and 8 mm; cylindrical cross-section of microchannel inner diameter is 50 mm.; Claim 9: wherein the method according to claim 1, wherein said viscoelastic aqueous liquid comprises xanthan gum or hyaluronic acid, [0005, 0007, 0009, 0010, 0016, 0051, 0098], Claim 3, 15, 24, 36.
Regarding Claim 6, the TONER reference discloses the claimed invention, but is silent in regards to wherein said microchannel satisfies the formula L/D >= 2500.
The TONER reference discloses the claimed invention, however, but it is silent in regards to wherein the characterised in that said microchannel satisfies the formula L/D > 2000. While TONER teaches the microchannel has a length L , such that the flow within the channel is laminar, [0059, 0060], and a cross-sectional diameter D, [0030], Figure 10A-D, inner diameter 50 mm.
TONER teaches a process for fabricating the microfluidic device that includes a microchannel which can be fabricating with a desired shape e.g., straight line or other shape, and desired dimension, e.g., desired length, width, or other dimension, [0056].
Therefore since TONER teaches and suggests the microchannels dimensions are result effective variables, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the length and cross-sectional diameter so that the microchannel is characterised in that it satisfies the formula L/D >= 2500 so that particles within the microchannel can effectively be separated with sufficient spacing to minimize any multiparticle strings / agglomerates that disrupt the continuity of the particle trains, MPEP 2144.05(II) and 2143(I)(E).
Regarding Claim 10: wherein the method according to claim 1, wherein said viscoelastic aqueous liquid comprises from 0.2 wt.% to 0.4 wt.% xanthan gum, or from 0.1 wt.% to 0.75 wt.% hyaluronic acid, Example 2, [0007, 0097-0098, 00105].
The TONER reference discloses adding hyaluronic acid sodium salt to water, in the molecular weight of the HA can be between 350 kDa and 1650 kDa, but does not disclose the specific wt% is added.
Since the molecular weight of the HA can be between 350 kDa and 1650 kDa, this is considered to be a result effective variables, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the wt% of the hyaluronic acid so that it is a 0.1 wt.% to 0.75 wt.% hyaluronic acid to dampen turbulent eddies near channel walls, shifting flow toward a smoother, more laminar pattern.
Regarding Claims 11 and 14, the reference TONER discloses the claimed invention, but is silent in regards to wherein the said mixture flows through said microfluidic device at a rate of from 0.3 ml/min to 15 ml /min.
However, TONER discloses a pump is operated to drive fluid through the channel at a volumetric flow rate that results in the formation of a localized pathline in the fluid at or near a center of the channel, [0053].
Since it is known in the art that a pumps can vary the flow rate of a fluid , it is considered to be a result effective flow rate. Therefore, it would be obvious to one having ordinary skill in the art to modify the flow rate in the microchannel so that said mixture flows through said microfluidic device at a rate of from 0.3 ml/min to 15 ml /min or 1 ml//min to 15 ml to provide conditions with optimal particle separation and minimizing particle double and triplet formation and condition optical for to prepare encapsulated separated particles.
Claims 15-18 are obvious over TONER, WO 2015/116990 A1 and further in view of KIM, WO 2013/192310 A1.
Regarding Claim 15, the TONER reference disclose the method according to claim 1, see Rejection to Claim 1 above, but is silent in regard to wherein: said microchannel has a second inlet positioned downstream of said first inlet at a distance that satisfies the formula L/D > 2000, wherein L represents the distance between inlets and D represents the cross-sectional diameter of said microchannel.
However, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the number of inlets the microchannel to increase the amount and type of fluid to be administered into the channel and as the mere duplication of parts has no patentable weight unless a new and expected result is produced, In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
In addition, TONER teaches a process for fabricating the microfluidic device that includes a microchannel which can be fabricating with a desired shape e.g., straight line or other shape, and desired dimension, e.g., desired length, width, or other dimension, [0056].
Therefore since TONER teaches and suggests the microchannels dimensions are result effective variables, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the length and cross-sectional diameter so that the microchannel is characterised in that it satisfies the formula L/D > 2000 so that particles within the microchannel can effectively be separated with sufficient spacing to minimize any multiparticle strings / agglomerates that disrupt the continuity of the particle trains, MPEP 2144.05(II) and 2143(I)(E).
Furthermore, the KIM reference discloses a method in a microfluidic device, abstract, the method comprising:
providing a microfluidic device comprising at least one microchannel, the microchannel comprising at least one first inlet and at least one first outlet, page 63 line 10-23, ;
forming a mixture by suspending said particles in an aqueous liquid, abstract, page 64 line 10-32; and
introducing said mixture into said microchannel via said first inlet and flowing said mixture through said microchannel at a flow rate (Q), characterised in that said microchannel satisfies the formula L/D, wherein L represents the length of said microchannel and D represents the cross-sectional diameter of said microchannel, page 64 line 10-32, wherein: said microchannel has a second inlet positioned downstream of said first inlet at a distance, page 2 line 25-32, said method further comprises, whilst introducing said mixture into said microchannel via said first inlet, simultaneously introducing a water immiscible encapsulation liquid into the microfluidic device via said second inlet at a flow rate (Q'), thereby producing droplets containing separated particles, page 2 line 25 – page 3 line 6, page 3 line 25-page 4 line 30.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the TONER reference with a second inlet positioned downstream of said first inlet at a distance as taught by KIM to from a three-dimensional patter of particles containing at least two symmetrical microvorticies that from simultaneously, page 4 line 4-6.
Regarding Claim 16, the references TONER in view of KIM suggest the claimed invention. The KIM further teaches the wherein said encapsulation liquid is a mineral oil, KIM page 57 line 1-4, optionally, having a viscosity of from 15 to 45 mPa s.
Regarding Claim 17, the combination of TONER in view of KIM suggest the claimed invention, including the aqueous solution, viscoelastic liquid and the encapsulation liquid, therefore it is an inherent property of the combination the interfacial tension would be expected to be the between 2 mN/m and 4 mN/m, page 53 line 17-25.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Regarding Claim 18, the references TONER in view of KIM suggest the claimed invention, but is silent in regards to wherein the said encapsulation liquid is introduced into said microchannel at a flow rate (Q') of from 0.3 ml/min to 15 ml /min.
However, TONER discloses a pump is operated to drive fluid through the channel at a volumetric flow rate that results in the formation of a localized pathline in the fluid at or near a center of the channel, [0053].
Since it is known in the art that a pumps can vary the flow rate of a fluid , it is considered to be a result effective flow rate. Therefore, it would be obvious to one having ordinary skill in the art to modify the flow rate in the microchannel so that said mixture flows through said encapsulation liquid is introduced into said microchannel at a flow rate (Q') of from to provide conditions with optimal particle separation and minimizing particle double and triplet formation and condition optical for to prepare encapsulated separated particles.
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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