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
Responsive to communication entered 08/20/2025.
Priority
This application, Pub. No. US 2019/0290829 A1, published 09/26/2019, is a § 371 National Stage of International Patent Application No. PCT/US2017/030232, filed 04/28/2017, Pub. No. WO 2018/022158 A1, published 02/01/2018, which claims priority to US provisional application 62/367,773, filed·07/28/2016.
Status of Claims
Claims 1-62 are currently pending. Claims 1-62 have been originally pending and subject to election/restriction requirement mailed 12/08/2023. Claim 63 has been added as set forth in Applicant’s amendment filed 02/08/2024. Claims 30 and 42 have been amended, and Claim 63 has been cancelled, as set forth in Applicant’s amendment filed 08/12/2024. Claim 30 has been amended, as set forth in Applicant’s amendment entered 01/24/2025. Claim 30 has been amended, as set forth in Applicant’s amendment filed 08/20/2025. Claims 1-29, 35-39 and 54-62 are withdrawn from consideration. Claims 30-34 and 40-53 are examined.
Withdrawn Objections/Rejections
Any objection or rejection not reiterated herein has been withdrawn.
The objection to Claim 30 is withdrawn in view of Applicant’s amendment of the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 30-34 and 40-53 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention (“new matter”).
This rejection is maintained from the previous Office Action.
The claims, as recited in the amended independent Claim 30, are drawn to:
PNG
media_image1.png
266
1074
media_image1.png
Greyscale
PNG
media_image2.png
496
1070
media_image2.png
Greyscale
There appears to be no explicit, implicit or inherent support for recitation “the target cells accumulate within primary streams along peripheral regions of the microfluidic separation channel” because the application is filed is limited to the embodiment wherein the target cells accumulate within two primary streams at the periphery of the separation channel and the non-target cells accumulate within a central secondary stream. See paragraph [0116] of Pub. No. US 2019/0290829 A1:
PNG
media_image3.png
168
596
media_image3.png
Greyscale
PNG
media_image4.png
226
552
media_image4.png
Greyscale
PNG
media_image5.png
124
544
media_image5.png
Greyscale
Emphasis added.
Applicant is reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I. MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. ... If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. This conclusion will result in the rejection of the claims affected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.112, first paragraph - description requirement, or denial of the benefit of the filing date of a previously filed application, as appropriate” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Emphasis added.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30-32 and 48-53 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Spain et al., US 2014/0209542, published 07/31/2014 (PTO-892 mailed 03/12/2024).
This rejection is maintained from the previous Office Action.
Regarding Claims 30 and 31, Spain et al. teach a system for cleansing blood by removing organophosphates:
PNG
media_image6.png
199
603
media_image6.png
Greyscale
PNG
media_image7.png
326
592
media_image7.png
Greyscale
PNG
media_image8.png
402
590
media_image8.png
Greyscale
PNG
media_image9.png
196
606
media_image9.png
Greyscale
PNG
media_image10.png
88
603
media_image10.png
Greyscale
PNG
media_image11.png
166
607
media_image11.png
Greyscale
PNG
media_image12.png
331
600
media_image12.png
Greyscale
Emphasis added.
Regarding Claim 32, Spain et al. teach a system further comprising at least two microfluidic separation channels connected in parallel (Fig. 3) and a manifold (paragraph [0070]: “The manifold system 107 distributes the whole blood and lipid-based capture particles to a plurality of separation channels contained within the microfluidic flow chamber 108.”).
Regarding Claim 48, Spain et al. teach a system further comprising a first collection channel in fluid communication with the first outlet and a second collection channel in fluid communication with the second outlet (paragraph [0070]: “As the whole blood flows through the microfluidic flow chamber 108, cleansed blood flows to a first outlet 110. After exiting the first outlet 100, the cleansed blood returns to the patient 101, via a second intravenous line 111. The lipid-based capture particles and other waste material removed from the blood exit the microfluidic flow chamber 108 via a second outlet 112.”)
Regarding Claim 49, Spain et al. teach that the second collection channel comprises a recycle line in fluid communication with the source of the biofluid, configured to recycle target particle depleted fluid from the second outlet to the source of the biofluid (paragraph [0070]: “After exiting the first outlet 100, the cleansed blood returns to the patient 101, via a second intravenous line 111. The lipid-based capture particles and other waste material removed from the blood exit the microfluidic flow chamber 108 via a second outlet 112. Next, the waste material and lipid-based capture particles enter a waste collection unit 113. In the waste collection unit 113, the lipid-based capture particles are separated from the waste material. Once separated, the waste material is discarded and the lipid-based capture particles are returned to the reservoir 107 by tubing 114. Once returned to the reservoir 107, the lipid-based capture particles are reused in the system to remove additional waste material from whole blood as it continues to flow through the system.”)
Regarding Claim 50, Spain et al. teach a system wherein the first or second collection channel is in fluid communication with a collection vessel (paragraph [0070]: “Next, the waste material and lipid-based capture particles enter a waste collection unit 113. In the waste collection unit 113, the lipid-based capture particles are separated from the waste material. Once separated, the waste material is discarded and the lipid-based capture particles are returned to the reservoir 107 by tubing 114. Once returned to the reservoir 107, the lipid-based capture particles are reused in the system to remove additional waste material from whole blood as it continues to flow through the system.”)
Regarding Claims 51-52, Spain et al. teach a system capable of intraluminal connection to a patient (Fig. 1).
Regarding Claim 53, Spain et al. teach a system wherein the microfluidic channel is formed from a thermoplastic material (paragraph [0106]: “For separation channels 400 formed from a thermoplastic, such as polystyrene, polyimide, polyacrylic, or polysulfone, the width of the lumen 403 in the bottom layer 402 is less than the one-half the wavelength of the acoustic wave in the fluid. In some implementations, the width of the lumen 403 in a thermoplastic separation channel 400 is between about one-fourth and three-eighths the wavelength of the acoustic wave in the fluid (i.e., about 25%-50% narrower than the half the wavelength, as suggested above). The shorter width results from the smaller impedance mismatch between the thermoplastic walls of the separation channel and the fluid passed through the channel. This lower mismatch provides imperfect acoustic reflection, thereby motivating the narrower channel. Particularly in comparison to glass or silicon-based separation channels, thermoplastic separation channels are substantially less expensive to manufacture.”)
As such, Spain et al. teach all the structural limitations of Claims 30-32 and 48-53. Although Spain et al. do not teach that a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid and a source of a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target cells, size of the non-target cells, compressibility of the biofluid, compressibility of the target cells, compressibility of the non-target cells, aggregation potential of the target cells, and aggregation potential of the non-target cells; and applying acoustic energy to the pretreated biofluid, such that the target cells accumulate within a primary stream along one of the a peripheral regions of the microfluidic separation channel and the non-target cells accumulate within a secondary stream along a central region of the microfluidic separation channel, Applicant is reminded that, according to MPEP 2114, "while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function." A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb
Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material.” The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.). Emphasis added.
Claims 30-32 and 48-53 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by Sun et al., US 2016/0030660, published 02/04/2016 (IDS submitted 02/04/2020).
This rejection is maintained from the previous Office Action.
The applied reference constitutes prior art under 35 U.S.C. 102(a)(1) because it has been published before the effective filing date of the instant application.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 30, Sun et al. teach a system for microfluidic separation (Abstract, Figs. 1-2) comprising:
At least one channel (202) comprising at least one inlet (203), a first outlet (204 leading to 206a) and a second outlet (204 leading to 206b);
A source of the biofluid (101/102, paragraph [0027]) in fluid communication with the at least one inlet of the channel;
A source of an additive (115) in fluid communication with the source of the biofluid (via 104), configured to introduce at least one additive into the biofluid (see “capture particle”, paragraph [0027]), the additive capable of altering at least one of size of the target particles, size of the non-target particles, compressibility of the biofluid, compressibility of the target particles, or compressibility of the non-target
particles (paragraph [0081]); and
At least one acoustic transducer (208) coupled to a wall of the at least one microfluidic separation channel.
Regarding Claim 31, Sun et al. teach a system wherein the acoustic transducer is positioned to apply a standing acoustic wave transverse to the microfluidic separation channel (Fig. 2, paragraph [0051).
Regarding Claim 32, Sun et al. teach a system further comprising at least two microfluidic separation channels connected in parallel (Fig. 2) and a manifold (205) configured to distribute biofluid to the at least two microfluidic separation channels.
Regarding Claim 48, Sun et al. teach a system further comprising a first collection channel (206a) in fluid communication with the first outlet (204) and a second collection channel (REF 206b) in fluid communication with the second outlet.
Regarding Claim 49, Sun et al. teach that the second collection channel (via 110, Fig. 1) comprises a recycle line (111) in fluid communication with the source of the biofluid, configured to recycle target particle depleted fluid from the second outlet to the source of the biofluid.
Regarding Claim 50, Sun et al. teach a system wherein the first or second collection channel is in fluid communication with a collection vessel (113).
Regarding Claims 51 and 52, Sun et al. teach a system capable of intraluminal connection to a patient (Fig. 1).
Regarding Claim 53, Sun et al. teach a system wherein the microfluidic channel
is formed from a thermoplastic material (paragraph [0045]).
As such, Sun et al. teach all the structural limitations of Claims 30-32 and 48-53. Although Sun et al. do not teach that a system for microfluidic cell separation configured to separate target cells from non-target cells in a biofluid and a source of a source of an additive in fluid communication with the source of the biofluid, configured to introduce at least one additive into the biofluid, the additive capable of altering at least one of size of the target cells, size of the non-target cells, compressibility of the biofluid, compressibility of the target cells, compressibility of the non-target cells, aggregation potential of the target cells, and aggregation potential of the non-target cells; and applying acoustic energy to the pretreated biofluid, such that the target cells accumulate within a primary stream along one of the a peripheral regions of the microfluidic separation channel and the non-target cells accumulate within a secondary stream along a central region of the microfluidic separation channel, Applicant is reminded that, according to MPEP 2114, "while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function." A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb
Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material.” The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.). Emphasis added.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 30-34, 40-42, 44 and 48-53 are rejected under 35 U.S.C. 103 as being unpatentable over Spain et al., US 2014/0209542, published 07/31/2014 (PTO-892 mailed 03/12/2024), in view of Aider et al., US 2014/0230912 published 08/21/2014 (IDS submitted 02/04/2020).
This rejection is maintained from the previous Office Action.
The teachings of Spain et al. with regard to Claims 30-32 and 48-53 are discussed above and incorporated herein in its entirety.
Regarding Claim 33, while Spain et al. teach monitoring flow or pressure in the microfluidic network (paragraph [0071]), this reference does not explicitly teach a system comprising a sensor configured to measure an input biofluid load on the system. However, Aider et al. teach an acoustophoretic system (Abstract, Figs. 1-7) comprising a sensor to measure an input biofluid load on the system (paragraphs [0089]-[0098]). It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified Spain et al. to include a sensor system, taught by Aider et al., in order to measure characteristics of a fluid or component in the fluid to control downstream operation of the acoustic transducer.
Regarding Claim 34, Spain et al. in view of Aider et al. teach that the manifold system is in communication with a sensor system configured to distribute fluid through said manifold in response to a measurement of said sensor system (paragraph [0029]).
Regarding Claim 40, Aider et al. teach a sensor system configured to measure at least one parameter of an output suspension (paragraphs [0089]-[0094]).
Regarding Claim 41, Aider et al. teach a sensor configured to measure a concentration of target particles or non-target particles in the output suspension (paragraphs [0094], [0098]).
Regarding Claim 42, Aider et al. teach a control module in communication with the sensor and an acoustic transducer, configured to regulate one of power, voltage, and frequency delivered to the acoustic transducer in response to a measurement of the at least one parameter in the output suspension (paragraphs [0089]-[0094]).
Regarding Claim 44, Aider et al. teach a sensor system configured to measure concentration of target particles or non-target particles (paragraphs [0089]-[0098]).
Claims 30-34, 40-42, 44 and 48-53 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al., US 2016/0030660, published 02/04/2016 (IDS submitted 02/04/2020) in view of Aider et al., US 2014/0230912 published 08/21/2014 (IDS submitted 02/04/2020).
This rejection is maintained from the previous Office Action.
The teachings of Sun et al. with regard to Claims 30-32 and 48-53 are discussed above and incorporated herein in its entirety.
Regarding Claim 33, while Sun et al. teach monitoring flow or pressure in the microfluidic network (paragraph [0029]), this reference does not explicitly teach a system comprising a sensor configured to measure an input biofluid load on the system. However, Aider et al. teach an acoustophoretic system (Abstract, Figs. 1-7) comprising a sensor to measure an input biofluid load on the system (paragraphs [0089]-[0098]). It would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have modified Sun et al. to include a sensor system, taught by Aider et al., in order to measure characteristics of a fluid or component in the fluid to control downstream operation of the acoustic transducer.
Regarding Claim 34, Sun et al. in view of Aider et al. teach that the manifold system is in communication with a sensor system configured to distribute fluid through said manifold in response to a measurement of said sensor system (paragraph [0029]).
Regarding Claim 40, Aider et al. teach a sensor system configured to measure at least one parameter of an output suspension (paragraphs [0089]-[0094]).
Regarding Claim 41, Aider et al. teach a sensor configured to measure a concentration of target particles or non-target particles in the output suspension
(paragraphs [0094], [0098]).
Regarding Claim 42, Aider et al. teach a control module in communication with the sensor and an acoustic transducer, configured to regulate one of power, voltage, and frequency delivered to the acoustic transducer in response to a measurement of the at least one parameter in the output suspension (paragraphs [0089]-[0094]).
Regarding Claim 44, Aider et al. teach a sensor system configured to measure concentration of target particles or non-target particles (paragraphs [0089]-[0098]).
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 30-34 and 40-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18 of US Patent No. 12,332,235 B2, issued 06/17/2025.
This rejection is modified from the provisional rejection set forth in the previous Office Action in view of issue of Application No. 18/528,061 (‘061 application), filed 12/04/2023, US 2024/0110908 A1, published 04/04/2024.
Although the claims at issue are not identical, they are not patentably distinct from each other because US Patent No. 12,332,235 B2 claims:
PNG
media_image13.png
714
606
media_image13.png
Greyscale
PNG
media_image14.png
110
602
media_image14.png
Greyscale
PNG
media_image15.png
82
596
media_image15.png
Greyscale
Claims 30-34, 40-42, 44 and 48-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of U.S. Patent No. 9,504,780, issued 11/29/2016 (PTO-892 mailed 03/12/2024), which prior publication Spain et al., US 2014/0209542, published 07/31/2014 (PTO-892 mailed 03/12/2024), discussed in the 103 rejection above, in view of Aider et al., US 2014/0230912 published 08/21/2014 (IDS submitted 02/04/2020).
This rejection is maintained from the previous Office Action.
U.S. Patent No. 9,504,780 claims:
PNG
media_image16.png
494
603
media_image16.png
Greyscale
PNG
media_image17.png
284
605
media_image17.png
Greyscale
For the reasons set forth in the 103 rejection above, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have used a device, taught by combination of Spain et al. and Aider et al., in the instantly claimed system.
Claims 30-34, 40-42, 44 and 48-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-8 of U.S. Patent No. 9,974,898, issued 05/22/2018 (PTO-892 mailed 03/12/2024) from Appl. No. 15/362,068, which is a continuation of Appl. No. 14/168,822, which publication is Spain et al., US 2014/0209542, published 07/31/2014 (PTO-892 mailed 03/12/2024), discussed in the 103 rejection above, in view of Aider et al., US 2014/0230912 published 08/21/2014 (IDS submitted 02/04/2020).
This rejection is maintained from the previous Office Action.
U.S. Patent No. 9,974,898 claims:
PNG
media_image18.png
525
604
media_image18.png
Greyscale
PNG
media_image19.png
197
603
media_image19.png
Greyscale
For the reasons set forth in the 103 rejection above, it would have been prima facie obvious, before the effective filing date of the claimed invention, for one of ordinary skill in the art to have used a device, taught by combination of Spain et al. and Aider et al., in the instantly claimed system.
Response to Arguments
Applicant's arguments filed 08/20/2025 have been fully considered but they are not persuasive.
Claim Rejection - 35 USC § 112
At page 12 of the Remarks, Applicant argues that:
PNG
media_image20.png
410
1072
media_image20.png
Greyscale
The Examiner respectfully disagrees because recitation “the target cells accumulate within primary streams along peripheral regions of the microfluidic separation channel” is broader than the originally filed disclosure that is limited to the embodiment wherein the target cells accumulate within two primary streams at the periphery of the separation channel.
Claim Rejection - 35 USC § 102 and 103
At pages 14-16 of the Remarks, Applicant argues that:
PNG
media_image21.png
40
1080
media_image21.png
Greyscale
PNG
media_image22.png
310
1072
media_image22.png
Greyscale
PNG
media_image23.png
272
1072
media_image23.png
Greyscale
The Examiner respectfully disagrees for the following reasons.
First, the instant claims, as recited in independent Claim 30, require “at least one acoustic transducer coupled to a wall of the at least one microfluidic separation channel to apply acoustic energy to the pretreated biofluid, such that the target cells accumulate within primary streams along peripheral regions of the microfluidic separation channel and the non-target cells accumulate within a secondary stream along a central region of the microfluidic separation channel.”
Second, as indicated above, both Spain et al. and Sun et al. teach all the structural limitations of the system of Claims 30-32 and 48-53. Applicant is reminded that, according to MPEP 2114, "while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function." A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
“[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was “for mixing flowing developer material” and the body of the claim recited “means for mixing ..., said mixing means being stationary and completely submerged in the developer material.” The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.). Emphasis added.
Third, the Examiner cannot determine whether or not the system, taught by either Spain et al. or Sun et al. is not suitable for separation target cells from non-target cells in a biofluid. The Patent and Trademark Office does not have the facilities and resources to provide the factual evidence, and the burden is upon Applicant to present such factual evidence. See e.g. In re Best (195 USPQ 430 (CCPA 1977)) or Ex parte Phillips (28 USPQ2d 1302 (BPAI 1993)).
Double Patenting
At page 13 of the Remarks, Applicant argues that:
PNG
media_image24.png
636
1078
media_image24.png
Greyscale
The Examiner respectfully disagrees for the following reasons.
First, the claims of both U.S. Patent No. 9,504,780, which prior publication is Spain et al., and U.S. Patent No. 9,974,898, which prior publication is Sun et al., in view of Aider et al., teach all limitations of the instant Claims 30-34, 40-42, 44 and 48-53.
Second, as indicated above, the provisional rejection set forth in the previous Office Action is modified in view of issue of US Patent No. 12,332,235 B2 on 06/17/2025.
Accordingly, the rejections of the claims are maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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, GREGORY S EMCH can be reached on (571)272-8149. 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 the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678