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
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on May 11, 2026 is acknowledged. Claims 15-20 are withdrawn from further consideration.
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 7-8 and 14 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.
On line 2 of claim 7, the phrase “of a second size” is indefinite since a first size is not positively recited in claim 7 or any of the claims that claim 7 depends from.
On line 2 of claim 14, the phrase “the first outlet channel” lacks antecedent basis since claim 14 depends from claim 12, and claim 12 does not positively recite a first outlet channel. In order for this phrase to have proper antecedent basis, claim 14 should depend from claim 12. On lines 3-4 and lines 4-5 of claim 14, the phrase “the second outlet channel” lacks antecedent basis since claim 14 depends from claim 12, and claim 12 does not positively recite a second outlet channel. In order for this phrase to have proper antecedent basis, claim 14 should depend from claim 12.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7 of U.S. Patent No. 12,611,542. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a microfluidic device (see the “body” recited in claim 1 of U.S. Patent 12,611,642 and instant claim 1) comprising at least one inlet channel (see the “second” end of the body recited in claim 1 and the first and second transit channels recited in claim 7 of US 12,611,642, and instant claim 1), a microfluidic channel having a first portion fluidly connected to the at least one inlet channel (see the mixing channel comprising a microfluidic channel recited in claims 1-2 of US 12,611,642, and instant claim 1), and at least one outlet channel connecting to a second portion of the microfluidic channel (see the “first” end of the body recited in claim 1 of US 12,611,642, and instant claim 1), wherein the microfluidic channel has a plurality of dimples extending away from an axis of the microfluidic channel (see claim 1 in US 12,611,642 and instant claim 1). Both sets of claims also recite that the at least one inlet channel includes a first inlet channel and a second inlet channel (see the first and second transit channels recited in claim 7 of US 12,611,642, and instant claim 2), that the plurality of dimples are arranged circumferentially around the microfluidic channel (see claims 3 and 5 in US 12,611,642 and instant claim 4), that the plurality of dimples are arranged in sets that longitudinally overlap (see claims 4 and 5 in US 12,611,642 and instant claim 5), and that the plurality of dimples include a first set of dimples arranged longitudinally along the microfluidic channel and a second set of dimples arranged longitudinally along the microfluidic channel, wherein the first set of dimples and the second set of dimples are laterally offset (see claims 4-5 in US 12,611,642 and instant claim 6). Since the first and second sets of dimples recited in the claims of US 12,611,642 are arranged longitudinally along the microfluidic channel and are laterally offset from one another, the first and second sets of dimples recited in the claims of US 12,611,642 would also be expected to be configured to separate nanoparticles by size.
Inventorship
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.
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.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tonkovich et al (US 2009/0326279, submitted in the IDS filed on May 11, 2026).
With regards to claim 1, Tonkovich et al teach of a microfluidic device comprising at least one inlet channel (see the left-hand side opening of the channel depicted in Figures 23 and 24 of Tonkovich et al where a “flow” is introduced into the microfluidic device), a microfluidic channel having a first portion fluidly connected to the at least one inlet channel (see the microfluidic channel depicted in Figures 23 and 24 of Tonkovich et al that has a “channel gap” and a “channel width”), and at least one outlet channel fluidly connected to a second portion of the microfluidic channel (see the right-hand side opening of the channel depicted in Figures 23 and 24 of Tonkovich et al), wherein the microfluidic channel has a plurality of dimples extending away from an axis of the microfluidic channel (see the “surface features” or dimples or protrusions that extend outwardly from the walls of the microfluidic channel depicted in Figures 23 and 24 of Tonkovich et al). Also, see paragraphs 0043-0044 and 0152 in Tonkovich et al.
With regards to claim 3, Tonkovich et al teach that the microfluidic device can comprise a first outlet channel 232 and a second outlet channel 234. See Figure 3 and paragraph 0195 in Tonkovich et al.
With regards to claim 4, Tonkovich et al teach that the plurality of dimples are arranged circumferentially around the microfluidic channel since the dimples are located on all different sides of the microfluidic channel, as depicted in Figures 23 and 24 of Tonkovich et al.
With regards to claim 5, Tonkovich et al teach that the plurality of dimples are arranged in sets that longitudinally overlap. See the lower drawing depicted in Figures 23 and 24 of Tonkovich et al where different sets of dimples are shown in longitudinal rows that overlap with one another.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 206103829, submitted in the IDS filed on May 11, 2026).
With regards to claim 1, CN 206103829 teaches of a microfluidic device comprising at least one inlet channel 5 (see both inlet channels 5 in Figure 1 of CN 206103829 where a fluid is introduced into the microfluidic device), a microfluidic channel 3 having a first portion fluidly connected to the at least one inlet channel 5 (see the microfluidic channel 3 depicted in Figure 1 of CN 206103829 that is connected to the inlet channels 5), and at least one outlet channel 2 fluidly connected to a second portion of the microfluidic channel (see outlet channel 2 depicted in Figure 1 of CN 206103829), wherein the microfluidic channel has a plurality of dimples 6 extending away from an axis of the microfluidic channel (see the dimples 6 that extend outwardly from the walls of the microfluidic channel depicted in Figure 1 of CN 206103829).
With regards to claim 2, CN 206103829 teaches that the at least one inlet channel of the microfluidic device comprises a first and a second inlet channel. See both the inlet channels labeled as “5” in Figure 1 of CN 206103829.
Claim Rejections - 35 USC § 103
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.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tonkovich et al (US 2009/0326279, submitted in the IDS filed on May 11, 2026). For a teaching of Tonkovich et al, see previous paragraphs in this Office action.
With regards to claim 6, Tonkovich et al teach that the plurality of dimples includes a first set of dimples arranged longitudinally along the microfluidic channel and a second set of dimples arranged longitudinally along the microfluidic channel, wherein the first set of dimples and the second set of dimples are laterally offset (see the lower drawing depicted in Figures 23 and 24 of Tonkovich et al where different sets of dimples are shown in longitudinal rows that overlap with one another), but does not specifically teach that the first set of dimples and the second set of dimples are configured to separate nanoparticles by size. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the first set of dimples and the second set of dimples in the microfluidic device taught by Tonkovich et al are also configured to separate nanoparticles by size because the sets of dimples in the microfluidic device taught by Tonkovich et al are arranged along the same longitudinal axis of the microfluidic channel as recited in instant claim 6 and are laterally offset from one another, so therefore, one of ordinary skill in the art would expect the first and second sets of dimples taught by Tonkovich et al to perform the same function of separating nanoparticles by size as performed by the sets of dimples in the microfluidic device recited in instant claim 6.
With regards to claims 7 and 8, Tonkovich et al fail to teach that the first and second sets of dimples in the microfluidic device have different widths or diameters in the specific ranges recited in instant claim 8. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the widths or diameters of the first and second sets of dimples in the microfluidic device taught by Tonkovich et al different from one another and in the size ranges recited in instant claim 8 because Tonkovich et al teach that the dimples are used for mixing and disrupting a laminar flow in the microfluidic channel (see paragraph 0152 in Tonkovich et al), and making the widths or diameters of the sets of dimples in the microfluidic channel different would help to further mix and disrupt the laminar flow of a fluid passed through the microfluidic channel.
With regards to claim 9, Tonkovich et al teach that the microfluidic device can comprise a first outlet channel 232 and a second outlet channel 234 (see Figure 3 and paragraph 0195 in Tonkovich et al), but fail to teach that the first set of dimples is arranged to guide nanoparticles of a first size to the first outlet channel, and the second set of dimples is arranged to guide nanoparticles of a second size to the second outlet channel. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the first set of dimples is arranged to guide nanoparticles of a first size to the first outlet channel, and the second set of dimples is arranged to guide nanoparticles of a second size to the second outlet channel in the microfluidic device taught by Tonkovich et al because the microfluidic device disclosed by Tonkovich et al has the same structure comprising first and second sets of longitudinally arranged and laterally offset dimples, a first outlet channel, and a second outlet channel as recited in instant claim 9, so therefore, one of ordinary skill in the art would expect the first and second sets of dimples taught by Tonkovich et al to perform the same function of guiding nanoparticles of a first size to the first outlet channel and guiding nanoparticles of a second size to the second outlet channel.
Claim(s) 2 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tonkovich et al (US 2009/0326279, submitted in the IDS filed on May 11, 2026) in view of Jung et al (US 2022/0032303). For a teaching of Tonkovich et al, see previous paragraphs in this Office action.
With regards to claims 2 and 12-13, Tonkovich et al fail to teach that the microfluidic device comprises a first and a second inlet channel, and a third outlet channel in addition to the outlet channel 232 and outlet channel 234 depicted in Figure 3 of Tonkovich et al.
Jung et al teach of a microfluidic mixer device 100 for mixing fluids that comprises a first inlet 110 connected to a first microchannel 140 for introducing a first fluid into the device 100, a second inlet 120 connect to the first microchannel 140 for introducing a second fluid into the device 100, at least two or more disk-shaped mixing units 150 disposed along the microchannel 140 and located between the inlets 110, 120 and a channel 130 that leads into a second microchannel 230, and a first outlet 210 and a second outlet 220 located at the end of the second microchannel 230. Jung et al teach that the mixing units 150 in the first microchannel 140 serve to mix two different fluids introduced into the mixer device 100 through the inlets 110 and 120, and separating units 240 disposed along the second microchannel 230 serve to separate particles in the mixed fluid according to size. Jung et al teach that relatively large particles are concentrated at the center of the second microchannel 230 and exit the device 100 at first outlet 210 while smaller particles flow to the side of the second microchannel 230 and exit via the device 100 via the second outlet 220. See Figures 1 and 5, and paragraphs 0032-0035 and 0040-0047 in Jung et al.
With regards to claims 2 and 12, and based upon the combination of Tonkovich et al and Jung et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the microfluidic device taught by Tonkovich et al with a first inlet channel and a second inlet channel because Jung et al teach that multiple inlets in a microfluidic device allow different fluids to be separately introduced to the device for mixing of the two fluids. With regards to claim 13, and based upon the combination of Tonkovich et al and Jung et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the microfluidic device taught by Tonkovich et al with a third outlet channel in addition to the first and second outlet channels in the device because Jung et al teach that multiple outlets in a microfluidic mixing device allow for the exit of particles of different sizes from the device so that the different-size particles remain separated from one another.
Allowable Subject Matter
Claims 10-11 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 since the closest prior art references to Tonkovich et al and CN 206103829, described above, fail to teach or fairly suggest a microfluidic device that comprises a third outlet channel into addition to the first and second outlet channels, and a third set of dimples in addition to a first and second set of dimples arranged longitudinally along the microfluidic channel, wherein the third set of dimples is configured to guide nanoparticles of a second size to the third outlet channel.
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims since the closest prior art references to Tonkovich et al and CN 206103829, described above, fail to teach or fairly suggest a microfluidic device that comprises a first set of dimples arranged to guide nanoparticles of a first size to a first outlet channel, a second set of dimples arranged to guide nanoparticles of a second size to a second outlet channel, and a third set of dimples arranged to guide nanoparticles of the second size to the second outlet channel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Audeh et al (US 2025/0041220) who teach of a system for the administration of particle-based therapeutics comprising a first chamber for receiving a lipid solution, a second chamber for receiving nucleic acids, and a mixing channel in communication with the first and second chambers; and Nsamela et al (US 2025/0262602) who teach of a system for producing a mixture of fluids in a microfluidic channel to formulate a liposome-based medicament.
It is noted that the instant claims are not rejected under either 35 USC 102(a)(2) or 35 USC 103 using the references to Lee et al (both U.S. Patent no. 12,611,642 and its U.S. Publication no. US 2023/0105059, submitted in the IDS filed on May 11, 2026) since the effective filing date of these references with regards to the microfluidic channel having a plurality of dimples extending away from an axis of the microfluidic channel is October 4, 2022, which is after the effective filing date of the instant application (October 3, 2022). Provisional application no. 63/251,880, which both references to Lee et al claim priority to, does not disclose a microfluidic channel having a plurality of dimples extending away from an axis of the microfluidic channel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 9, 2026
Prosecution Insights