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 .
DETAILED ACTION
This is a response to an amendment filed April 15th, 2026. By the amendment claims 1-10, 12-14 and 18-20 with claims 1-2, 12 and 18 being amended and claims 11 and 15-17 being canceled. Unless otherwise stated the applicant’s amendments have overcome the 35 U.S.C 112 rejections as outlined in the previous Office action.
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, 3-4, and 12-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claim3-4, 12-13 and 16 of U.S. Patent No. 11,579,073. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '073 patent anticipate the claims of the instant application.
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Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 1 recites “wherein the trigger flow diverts the microfluidic chip from the particle flow.” The trigger flow diverts the particle not the microfluidic chip.
Claims 2-10 are rejected by virtue of their dependencies.
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.
Claims 1-10 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 1 is rendered indefinite for reciting “wherein the trigger flow diverts the microfluidic chip from the particle flow.” It is unclear how the trigger flow diverts the microfluidic chip. This claim will be interpreted as if it read “wherein the trigger flow diverts the particle from the particle flow.”
Claims 2-10 are rejected by virtue of their dependencies.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 6 and 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Takeda et al. (US 20180298324 A1), hereafter Takeda.
With regards to claim 1, Takeda discloses a particle sorter cartridge (Abstract), comprising: a microfluidic chip (flow path 4) including a sensing or detector region (35); and a body defining a plurality of reservoirs therein (Fig. 2A); and an interface plate (substrate 1 also 10 in some Figures) configured to connect to the body and to the microfluidic chip; configured such that upon detection of a particle in a particle flow within the sensing or detector region, a solution flow within the microfluidic chip is diverted by application of a trigger flow to at least one of: sort and isolate the detected particle from the particle flow (P122, L22-27); wherein the trigger flow diverts the particle from the particle flow in a non-perpendicular angle relative to the particle flow (Fig. 10 shows direction of trigger flow from 24L[Wingdings font/0xE0]24R; hitting the particle with a trigger flow perpendicular to the particle flow direction as shown in Fig. 2 will at least momentarily have a path of the particle be at a non-perpendicular angle).
With regards to claim 2 Takeda discloses all the elements of claim 1 as outlined above. Takeda further discloses wherein one or more of the microfluidic chip, the cartridge body, and the interface plate are disposable (P0113).
With regards to claim 3, Takeda discloses all the elements of claim 1 as outlined
above. Takeda further discloses wherein the plurality of reservoirs includes a sample reservoir (11), a control fluid reservoir (12), and a trigger reservoir (16; also labeled 3A in some figures).
With regards to claim 4 Takeda discloses all the elements of claim 1 as outlined above. Takeda further discloses wherein the trigger flow comprises fluid from the trigger reservoir (P0126, L9-10).
With regards to claim 6, Takeda discloses all the elements of claim 1 as outlined above. Takeda further discloses an optical detector that is operably coupled to the detector region (P0121, L9-12).
With regards to claim 9, Takeda discloses all the elements of claim 6 as outlined above. Takeda further discloses, wherein the detection of a particle in the detector region is based upon a signal generated by the optical detector (P0121, L9-12).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5, 7-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeda as applied to claim 1 above, and further in view of Sohn et al. (US 20020140414), hereafter Sohn.
With regards to claim 5 Takeda discloses all the elements of claim 1 as outlined above. Takeda further discloses an optical detector (P0121, L9-12). Takeda does not disclose an electrical detector.
However, Sohn discloses an electrical detector that is operably coupled to the
detector region (P033). It would have been obvious to a person with ordinary skill in the art to add the electrical detector as disclosed by Sohn to the device disclosed by Takeda to enable the separation of multiple types of particles with one device, for example if the particles being separated could not be separated using optical properties, but had different electrical impendences.
With regards to claim 7, Takeda and Sohn discloses all the elements of claim 5 as outlined above. Takeda further discloses an optical detector (P0121, L9-12).
With regards to claim 10, Takeda and Sohn discloses all the elements of claim 7 as outlined above. Takeda further discloses wherein the detection of a particle in the detector region is based upon at least one of: a signal generated by the electrical detector; and a signal generated by the optical detector (P0121, L9-12).
With regards to claim 8, Takeda and Sohn discloses all the elements of claim 5
as outlined above. Takeda does not disclose wherein the detection of a particle in the detector region is based upon a signal generated by the electrical detector. However, Sohn discloses wherein the detection of a particle in the detector region is based upon a signal generated by the electrical detector (P0033). Therefore, the combination of Takeda and Sohn discloses this feature.
Claims 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takeda (US 20180298324) in view of Nielsen et al. (US 8894946), hereafter Nielsen.
With regards to claim 12, Takeda discloses a particle sorting system (Abstract), comprising: a cartridge assembly (Abstract), the cartridge assembly including: a microfluidic chip (flow path 4) including a sensing or detector region (35) ; and a body (Fig. 2A) defining a plurality of reservoirs therein (11, 12, 16, 16 is also designated by 3A in some figures and is used interchangeably in the specification); the cartridge assembly configured such that, upon detection of a particle in a particle flow within the detector region, a solution flow within the microfluidic chip is diverted by application of a trigger flow to at least one of: sort and isolate the detected particle from the particle flow (P122, L22-27); wherein the trigger flow comprises fluid from the trigger reservoir (P0126, L9-10); wherein the trigger flow is gated by valving (92) and wherein the valving is external to the cartridge assembly (Fig. 10). Takeda does not disclose a base plate, the base plate configured to receive and connect to the cartridge assembly.
However, Nielsen discloses a base plate (port 102), the base plate configured to receive and connect to the cartridge assembly (Col. 8, L2-3). It would have been obvious to a person with ordinary skill in the art to add a base plate as disclosed by Nielsen to the system as disclosed by Takeda, in order to couple the cartridge to a control system.
With regards to claim 13, Takeda and Nielsen disclose all the elements of claim 12 as outlined above. Takeda further discloses wherein one or more of the microfluidic chip and the cartridge body are disposable (P0113).
With regards to claim 14, Takeda and Nielsen disclose all the elements of claim 12 as outlined above. Takeda further discloses wherein the plurality of reservoirs includes a sample reservoir (11), a control fluid reservoir (12), and a trigger reservoir (16, also designated as 3A in some figures used interchangeably in specification).
With regards to claim 18, Takeda and Nielsen disclose all the elements of claim 12 as outlined above. Takeda further discloses wherein the cartridge assembly is further configured such that upon application of a trigger flow, a solution flow within the microfluidic chip is diverted by application of a carrier flow to result in least one of: sorting the detected particle and isolate the detected particle from the particle flow (P122, L22-27).
With regards to claim 19, Takeda and Nielsen disclose all the elements of claim 18 as outlined above. Takeda further discloses wherein the carrier flow comprises fluid from the control fluid reservoir (P0070, L7).
With regards to claim 20, Takeda and Nielsen disclose all the elements of claim 19 as outlined above. Takeda does not directly disclose wherein the carrier flow is gated by valving.
However, Takeda discloses multiple reservoirs controlled by valves
(92, 93). It would have been obvious to a person with ordinary skill in the art to add a valve to the control fluid reservoir, in order to control the flow rate of the carrier, thus decreasing costs. This is considered a simple duplication of parts that are being used in the traditional manner (MPEP 2144.04.VI.B).
Response to Arguments
With regards to the Double Patenting rejection, the applicant is advised that the claim amendments are different than those presented in the arguments. The double patenting rejection has been edited according to the amendments to claim 12. With regards to the applicant’s arguments about Takeda and the amendments to claim 1, new grounds of rejection are presented above. Furthermore, the applicant is advised that the claims do not require a pressure to be maintained as argued.
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.
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/J.L.B./Examiner, Art Unit 3653
/MICHAEL MCCULLOUGH/Supervisory Patent Examiner, Art Unit 3653
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